Lybalvi's Details: Effects, Pricing, Quantity, and Additional Information
Lybalvi is a trademarked oral pill utilized for treating schizophrenia and bipolar I disorder. This medication is a fusion drug comprising two active components: olanzapine and samidorphan.
Drug characteristics
Below, you'll find critical information regarding Lybalvi.
- Drug categories: atypical antipsychotic and opioid antagonist
- Medical form: oral tablet
- Generics unavailable: at the moment
- Prescription necessary: yes
- Controlled substance: no
- FDA approval year: 2021
Lybalvi Generics
At present, Lybalvi is exclusively accessible as a branded medication. It is not yet available in generic form.
A generic drug is essentially an identical replica of the active substance in a brand-name drug. Generics typically cost less than brand-name drugs.
Lybalvi side effects
Lybalvi may cause mild to severe side effects. The following list includes several key side effects that may surface while using Lybalvi. This list does not encompass all potential side effects.
For further details about Lybalvi's conceivable side effects, consult your physician or pharmacist. They can provide you with guidance on managing any side effects that may concern or bother you.
Note: The Food and Drug Administration (FDA) monitors and reviews side effects of drugs it has authorized. If you wish to notify the FDA about a side effect you've experienced with Lybalvi, you can do so through MedWatch.
Mild side effects
Possible mild side effects of Lybalvi include:
- drowsiness
- dry mouth
- headache
- constipation
- heightened cravings
- wooziness
- trembling (shaking)
- weakness
- indigestion
- lower back pain
- speech difficulties
- boosted saliva production
- memory lapse (amnesia)
- swallowing problems
- numbness or tingling in your arms or legs
- elevated cholesterol levels
- weight acquisition†
Most of these side effects might diminish within a few days to a few weeks. However, if they aggravate or persist, consult your physician or pharmacist.
* This is a limited list of mild side effects from Lybalvi. For more information about other mild side effects, communicate with your doctor or pharmacist or view Lybalvi's prescribing information.† For additional information about this side effect, see “Side effect details” below.
Serious side effects
Serious side effects from Lybalvi are rare, but they may occur. Contact your doctor immediately if you encounter serious side effects. If your symptoms feel life-threatening or you believe you are suffering from a severe medical emergency, call 911 or your local emergency number.
Potent side effects and their symptoms can include:
- Drug reaction with eosinophilia and systemic symptoms (DRESS), which is a reaction that can manifest after taking certain medications. Symptoms could include:
- fever
- rash
- swollen lymph nodes
- Hyperglycemia (high blood sugar) or diabetes. Symptoms can include:
- feeling thirsty
- confusion
- blurry vision
- Orthostatic hypotension (dizziness upon changing positions) or fainting. Symptoms can include:
- dizziness
- blurry vision
- lightheadedness
- Declines in blood cell levels, such as low white blood cells. Symptoms can include:
- fever
- shivers
- sore throat
- Seizures. Symptoms can include:
- stiffening of the body
- convulsions
- loss of consciousness
- Abnormally high prolactin levels (a hormone produced in the brain). Symptoms can include:
- variations in menstrual cycles
- release of milky fluid (while not pregnant or nursing)
- headache
- Tardive dyskinesia (uncontrolled muscle movements). Symptoms can include:
- repetitive lip-smacking or lip-pursing
- sticking out the tongue
- rapid blinking
- Difficulty with temperature regulation. Symptoms can include:
- body overheating after excessive exercising or inadequate hydration
- Decreased mental clarity or reaction speed, which could make it dangerous to perform specific tasks, like driving
- Enhanced risk of death in elderly individuals with dementia-related psychosis.*†
- Allergic reaction.†
- Neuroleptic malignant syndrome (NMS).†
* Lybalvi has a boxed warning for this side effect. A boxed warning is the most serious warning from the FDA.† For more information about this side effect, see “Side effect details” below.*
Side effect details
Here are additional details about certain side effects this drug may cause. To discover the frequency of side effects in clinical trials, consult Lybalvi's prescribing information.
Weight gain
You might encounter weight gain while taking Lybalvi. In clinical trials, this side effect was frequent.
Many antipsychotic medications (including Lybalvi) can heighten your risk of weight gain. However, it's important to keep in mind that people taking Lybalvi in a trial for schizophrenia experienced less weight gain than those taking olanzapine alone (one of Lybalvi's active components).
If you find yourself putting on extra pounds while using Lybalvi, it's crucial to discuss this with your doctor. They might suggest adjusting your diet or workout routine to curb weight gain.
Though uncommon, there's a chance of developing neuroleptic malignant syndrome (NMS) while employing Lybalvi. This disorder arises due to a negative reaction to drugs utilized for mental health treatment.
Keep an eye out for potential NMS symptoms when taking Lybalvi. Seek medical attention immediately if you notice any symptoms, such as:
- High fever
- Mental confusion
- Sweating excessively
- Severe muscle rigidity
- Heart rate, pulse, or blood pressure changes
- Unusual breathing patterns
What to do
If you experience NMS symptoms, it's vital to reach out to your doctor or head to the hospital right away. Although rare, NMS can be life-threatening. If NMS develops, your doctor will treat it and suggest halting Lybalvi use.
Lybalvi carries a boxed warning regarding an elevated risk of death in senior adults with dementia-related psychosis. A boxed warning represents the Food and Drug Administration (FDA)'s most serious warning. These alerts notify doctors and patients about potentially harmful drug effects.
Antipsychotic drugs like Lybalvi might augment the risk of death in older adults with dementia-related psychosis (a condition characterized by memory loss). With psychosis, you lose touch with reality, and you might hear or see things that aren't real. Hallucinations or delusions might also occur.
Lybalvi raises the risk of death in this group of individuals. In studies involving olanzapine (Lybalvi's active ingredient), fatalities stemmed from various causes, including heart issues or infections such as pneumonia.
Stroke also struck older adults with dementia-related psychosis who took olanzapine during clinical trials. Stroke can be fatal for some people. Potential stroke symptoms include:
- Confusion
- Speaking, seeing, or walking difficulties
- Severe headache
- Weakness on one side of the body, usually affecting the face, arm, or leg
What to do
Lybalvi is not authorized for usage in dementia-related psychosis patients. If you are afflicted by this condition, your doctor can recommend more suitable treatment options.
If you experience stroke symptoms, immediately call 911 or your local emergency number.
Like most medications, some individuals may have an allergic reaction upon taking Lybalvi. Although not documented in Lybalvi's clinical trials, allergic reactions have been reported after the drug's launch.
Mild allergic reaction symptoms include:
- Skin rash
- Itchiness
- Flushing
A severe allergic reaction is rare but possible. Severe allergic reaction symptoms include:
- Swelling beneath the skin, often in the eyelids, lips, hands, or feet
- Swelling of the tongue, mouth, or throat
- Difficulty breathing
If you suffer from an allergic reaction to Lybalvi, promptly contact your doctor. In case your symptoms seem life-threatening or if you suspect a medical emergency, call 911 or your local emergency number.
Lybalvi Cost and Coupons
As with all medications, Lybalvi's price can fluctuate. The actual amount you pay is contingent on your insurance plan, location, and preferred pharmacy.
Remember that you may qualify for a 90-day supply of Lybalvi if authorized by your insurance company. This could reduce your pharmacy visits and help lower costs. If interested, consult your doctor, pharmacist, or insurance provider.
Prior authorization might be necessary from your insurance company before approving Lybalvi coverage. This entails communicating with your doctor and insurance provider about your prescription before coverage is provided. The insurance company will review the prior authorization request and determine whether the drug will be covered.
If unsure whether prior authorization is required for Lybalvi, contact your insurance provider.
Financial and Insurance Assistance
If you require financial aid to cover Lybalvi or assistance understanding your insurance coverage, help is available.
Lybalvi's manufacturer offers a copay savings card which can be used if you have insurance. To learn more and check eligibility, call 855-820-9624 or visit the manufacturer's website. You can also ask your doctor for more details.
Visit Optum Perks for Lybalvi price estimates. These estimates are based on the utilization of Optum Perks coupons. Note: Optum Perks coupons cannot be combined with insurance copays or benefits.
To learn more about saving money on prescriptions, see this article.
Mail-order Pharmacies
Lybalvi might be available through a mail-order pharmacy. Using this service could lower the drug's cost and permit you to obtain medication without leaving home.
If suggested by your medical professional, you might be eligible for a three-month supply of Lybalvi, alleviating concerns about medication shortage. If this option interests you, reach out to your doctor, pharmacist, or insurance company. Certain Medicare plans might aid in covering the expenses of mail-order medications.
In case you lack insurance coverage, you can discuss this with your doctor or pharmacist, exploring possibilities with online pharmacy services.
Generic equivalent
Lybalvi does not have an equivalent in a generic form. A generic medication contains the same active components as a name-brand drug. Generics often cost less than their brand-name counterparts.
Lybalvi dosage
The dosage of Lybalvi prescribed by your medical professional relies on various factors, including:
- the medical condition you're treating with Lybalvi
- other medications you're using alongside Lybalvi
- adverse effects caused by the medicine
Typically, your medical professional initiates therapy with a low dose. They will gradually adjust it, aiming to reach the optimal amount for you. Your doctor will ultimately prescribe the smallest dose necessary for achieving the desired effect.
The following information summarizes common dosages: however, always adhere to the dosage prescribed by your doctor. Your medical professional will determine the ideal dosage to meet your specific needs.
Drug forms and strengths
Lybalvi contains olanzapine and samidorphan as active components. It is available in tablet form, which must be swallowed, and is available in the following strengths:
- 5 mg olanzapine/10 mg samidorphan
- 10 mg olanzapine/10 mg samidorphan
- 15 mg olanzapine/10 mg samidorphan
- 20 mg olanzapine/10 mg samidorphan
Dosage for schizophrenia
For treating schizophrenia in adults, your doctor typically begins treatment with a dose of 5 mg/10 mg (5 mg of olanzapine and 10 mg of samidorphan) or 10 mg/10 mg once daily.
After each week of administration, your doctor may increase your dosage until your schizophrenia symptoms subside. The maximum recommended dosage for treating schizophrenia with Lybalvi is 20 mg/10 mg once daily.
Dosage for bipolar I disorder
Your Lybalvi dosage for bipolar I disorder depends on whether you're using it alone or in conjunction with other medications.
Lybalvi as a single treatment
Your physician might prescribe Lybalvi in isolation for managing mixed or manic episodes of bipolar I disorder. The initial dosage for this condition is usually 10 mg/10 mg or 15 mg/10 mg daily. Your doctor may fine-tune your dosage every 24 hours, aiming to find the right dosage for you.
The maximum recommended dosage of Lybalvi for bipolar I disorder is 20 mg/10 mg once daily.
Once your symptoms improve, your doctor might recommend long-term Lybalvi use.
Lybalvi in combination with lithium or valproate
Your doctor might recommend using Lybalvi in conjunction with lithium (Lithobid) or valproate for bipolar I disorder management. In such cases, you would typically initiate therapy with a daily dose of 10 mg/10 mg. Your doctor may then progressively increase your dosage based on the medication's efficacy for you.
The maximum recommended dosage of Lybalvi when combined with lithium or valproate for bipolar I disorder is 20 mg/10 mg daily.
Lybalvi for long-term maintenance as a monotherapy
Lybalvi can also be employed for long-term maintenance as a single therapy to treat bipolar I disorder. In this case, your doctor might recommend a daily dose from the following options:
- 5 mg/10 mg
- 10 mg/10 mg
- 15 mg/10 mg
- 20 mg/10 mg
Missed dose
If you miss a Lybalvi dose, address the matter with your doctor or pharmacist. Based on how long it's been since you missed your dose, they can help you determine the best course of action.
Occasionally, your doctor may advise taking your missed dose as soon as you remember. In other scenarios, they may recommend skipping your missed dose and sticking to your regular schedule.
To reduce the likelihood of missing a dose, consider employing a medication reminder. This can involve setting an alarm or utilizing a timer. Alternatively, you could install a reminder app on your phone.
Duration of use
Lybalvi might be used for both short-term and long-term treatment. For schizophrenia, ongoing use is typically required. However, for manic or mixed episodes of bipolar I disorder, the drug might be used short or long-term, depending on the collaboration between you and your doctor. If Lybalvi is deemed safe and effective for you, prolonged use can be anticipated.
One of Lybalvi's key components is samidorphan, which is a type of opioid antagonist. Its role in Lybalvi is to inhibit opioids, preventing them from functioning. However, samidorphan is utilized in Lybalvi to reduce the weight gain that can emerge as a side effect of the medication. Lybalvi does not include any opioid medication itself.
Controlled substances are drugs that the government regulates, frequently due to the potential for addiction or misuse. With addiction, your body becomes reliant on the drug to function as usual. Misusing a medication means utilizing it in a manner unlike that prescribed by a doctor. Opioids fall under controlled substances since they can lead to addiction and misuse.
It's crucial to avoid taking Lybalvi if you're currently on opioid medication. Given that samidorphan targets the opioid receptor (where opioids exert their effects), consuming this medication within 7 days of a short-acting opioid or 14 days of a long-acting opioid may induce withdrawal symptoms. These symptoms may escalate to the point of hospitalization.
When taking opioid medication while on Lybalvi, you might require a higher dose to experience the full effect of the opioid. However, this increase in dose may risk an unintended overdose of the opioid.
If you have any inquiries or concerns about taking Lybalvi, you should consult your physician or pharmacist.
* For further information about this side effect, refer to the “Lybalvi side effects” section above.
What distinguishes Lybalvi from Zyprexa (olanzapine)?
Both Lybalvi and Zyprexa are employed to manage schizophrenia and bipolar I disorder in adults. Medical professionals may also recommend Zyprexa for these conditions in certain children. Additionally, the Food and Drug Administration (FDA) has authorized Zyprexa for other uses.
Clinical tests have demonstrated that Lybalvi and Zyprexa are effective in dealing with schizophrenia and bipolar I disorder.
Both drugs incorporate the active ingredient olanzapine. However, Lybalvi also includes an additional active ingredient, samidorphan, which is thought to aid in preventing weight gain. Weight gain is a common side effect of atypical antipsychotics such as Lybalvi and Zyprexa.
In clinical trials, individuals who took Lybalvi for schizophrenia reported less weight gain compared to those who took olanzapine alone.
To gain a more detailed understanding of how Lybalvi and Zyprexa differ, you should consult your physician or pharmacist.
Which activities should I avoid while taking Lybalvi?
Due to certain potential side effects related to Lybalvi, you should refrain from operating a vehicle or machinery until you've become accustomed to Lybalvi's impact on your body. Lybalvi can cause drowsiness, dizziness, or tremors. It may also induce more severe side effects like fainting or seizures. These side effects may affect your ability to safely operate a vehicle or machinery.
Additionally, becoming overheated or dehydrated during your Lybalvi treatment heightens your risk of experiencing orthostatic hypotension or fainting. Methods to prevent overheating or dehydration include:
- avoiding excessive exercise
- staying in a cool, shaded area
- wearing light clothing
- remaining hydrated
- avoiding alcohol
If you have further questions regarding activities to avoid during your Lybalvi treatment, talk to your doctor.
Can Lybalvi induce any changes in my personality?
Lybalvi has not been linked to personality changes in clinical trials. No instances of personality changes were reported as side effects. However, this medication does facilitate mood stabilization. Consequently, you may observe that your mood and behavior are more manageable while taking Lybalvi. You might experience fewer symptoms of schizophrenia or bipolar I disorder more frequently.
If you're concerned about personality changes while using Lybalvi, discuss your concerns with your doctor. They can determine whether Lybalvi might be an appropriate treatment option for you.
How Lybalvi functions
Lybalvi is approved for managing schizophrenia and bipolar I disorder in adults. It includes two active ingredients: olanzapine and samidorphan.
The specific mechanism through which Lybalvi operates to treat schizophrenia or bipolar I disorder remains unknown. However, it's speculated that olanzapine may obstruct the effects of dopamine and serotonin (brain hormones) by binding to their receptors. This could help balance your mood, reducing the symptoms of schizophrenia or bipolar I disorder.
Lybalvi also contains samidorphan, an opioid antagonist, which was incorporated to reduce the weight gain* that olanzapine might induce. Although weight gain remains a possibility with Lybalvi, individuals taking Lybalvi reported less weight gain than those who took olanzapine alone.
* For more information about this side effect, see the “Lybalvi side effects” section above.
How long does it take to take effect?
Lybalvi begins working immediately after you ingest your initial dose of medication. However, it might take up to 7 days for the medication to reach a consistent level in your body. Thus, it might take some time before you perceive any changes in your mood.
Lybalvi is utilized to address adult cases of schizophrenia and bipolar I disorder, both being mental health issues. Delve deeper into mental health matters through our dedicated mental health resource center – the mental health hub.
Lybalvi and Schizophrenia
One application of Lybalvi is in the management of schizophrenia in grown-ups. Schizophrenia is a mental health problem that can potentially impact sensory perceptions. Symptoms may manifest as hallucinations, distorted thought processes, and unfounded beliefs.
Efficiency for Schizophrenia
Lybalvi shows promising results in tackling schizophrenia. The 2020 American Psychiatric Association guidelines acknowledge olanzapine, one of Lybalvi's components, as an effective treatment option for schizophrenia. However, although Lybalvi was authorized in 2021, it hasn't been incorporated into these guidelines yet. To comprehend Lybalvi's performance in clinical trials, examine its respective prescribing information.
Lybalvi and Bipolar I Disorder
Lybalvi is additionally approved for handling bipolar I disorder in adults. This mental health condition can lead to manic and depressive episodes.
Symptoms of manic episodes may encompass amplified energy levels or extreme confidence. Symptoms of depression may entail feelings of sadness or isolation or disinterest in activities usually enjoyed. For further insights into bipolar I disorder, refer to our bipolar disorder hub.
Lybalvi can be employed to address manic or mixed (co-occurring manic and depressed) episodes. It can be used singularly as either a short-term or long-term treatment option. In addition, individuals with bipolar I disorder can use Lybalvi in conjunction with lithium (Lithobid) or valproate.
Efficiency for Bipolar I Disorder
Clinical trials on olanzapine, an active ingredient in Lybalvi, have confirmed the drug's effectiveness in individuals with bipolar I disorder. To explore how olanzapine performed in clinical trials, examine Lybalvi's prescribing information.
Lybalvi and Children
At present, Lybalvi is not authorized for use in children. There's uncertainty surrounding whether the drug is a safe or suitable treatment option for children suffering from schizophrenia or bipolar I disorder.
Alternatives to Lybalvi
Additional medications can be employed to address your condition. Discuss alternatives with your doctor to find a drug that suits your needs best.
Note: Some drugs are prescribed off-label to treat these specific disorders. Off-label use refers to doctors prescribing a drug authorized by the Food and Drug Administration (FDA) for reasons beyond its approved usage.
Alternatives for Schizophrenia
Possible alternatives to manage schizophrenia include:
- aripiprazole (Abilify)
- cariprazine (Vraylar)
- lurasidone (Latuda)
- risperidone (Risperdal)
- olanzapine (Zyprexa)
- haloperidol (Haldol)
- paliperidone (Invega)
Alternatives for Bipolar I Disorder
Potential alternatives for managing bipolar I disorder include:
- lithium (Lithobid)
- valproate
- carbamazepine (Tegretol)
- lamotrigine (Lamictal)
- quetiapine (Seroquel)
- olanzapine (Zyprexa)
- fluoxetine (Prozac)
- escitalopram (Lexapro)
- paroxetine (Paxil)
Lybalvi Interactions
Lybalvi may interfere with various medications. Its interactions with food are not established, but it may affect certain supplements.
Varying interactions can result in differing consequences. Some interactions can diminish a drug's effectiveness, while others can increase or intensify side effects.
Lybalvi and Other Medications
The following medications can potentially interact with Lybalvi. This list does not include all potential drug interactions with Lybalvi.
Discuss Lybalvi with your doctor and pharmacist before initiating treatment. Share information about all prescription, over-the-counter, and additional drugs you take as well as any vitamins, herbs, and supplements you utilize. This data can assist in preventing potential interactions.
If you have concerns about drug interactions that might impact you, consult with your doctor or pharmacist.
Drugs not compatible with Lybalvi include:
- Opioids. These medications are often prescribed to manage pain. Lybalvi could instigate opioid withdrawal or exacerbate existing opioid withdrawal symptoms. Examples include:
- oxycodone (Roxicodone)
- hydromorphone (Dilaudid)
- morphine ER (MS Contin)
- methadone (Methadose)
Strong Inhibitors of CYP3A4. These substances influence a protein in your body called CYP3A4. Consuming Lybalvi alongside these medications may decrease Lybalvi's effectiveness. Examples of these medications include:- carbamazepine (Tegretol)- phenytoin (Dilantin)- rifampin (Rimactane)
Strong Inhibitors of CYP1A2. These medications hinder a protein named CYP1A2 from functioning in your body, thereby increasing your risk of Lybalvi side effects. Examples of these drugs include:- ciprofloxacin (Cipro)- fluvoxamine (Luvox)- omeprazole (Prilosec)
Inhibitors of CYP1A2. These drugs affect a protein in your body called CYP1A2. Taking Lybalvi with these medications may decrease Lybalvi's effectiveness. Examples of these medications include:- phenytoin (Dilantin)- ritonavir (Norvir)- rifampin (Rimactane)
Drugs impacting the Central Nervous System. Consuming these drugs together with Lybalvi may increase the risk of orthostatic hypotension. Examples of these medications include:- diazepam (Valium)- alprazolam (Xanax)- clonazepam (Klonopin)
Anticholinergic Drugs. Taking these drugs along with Lybalvi can enhance your risk of side effects, including digestive issues. Examples of these medications include:- benztropine- aclidinium (Tudorza Pressair)- amitriptyline
Certain Blood Pressure Medications. Lybalvi can lower your blood pressure further if taken alongside these medications. Examples of these medications include:- lisinopril (Zestril)- losartan (Cozaar)- metoprolol (Toprol-XL, Lopressor)
Drugs affecting Dopamine. Lybalvi can prevent these drugs from functioning. Examples of these medications include:- levodopa (Inbrija)- ropinirole- pramipexole (Mirapex ER)
Lybalvi and Herbs and Supplements
Lybalvi could interact with an herbal supplement called St. John’s wort. St. John’s wort stimulates a protein in your body called CYP3A4, causing it to work faster than usual. Taking Lybalvi with St. John’s wort may decrease Lybalvi’s effectiveness.
Before using any herbs or supplements while taking Lybalvi, consult your doctor or pharmacist.
Lybalvi and Food
If you consume alcohol, avoid it while taking Lybalvi. Alcohol can increase your risk of orthostatic hypotension, which may cause fainting or dizziness. For more information on this risk, see the “Lybalvi and alcohol” section below.
Lybalvi and Lab Tests
Lybalvi may produce false positives on urine tests for detecting opioids. In this case, a false positive means the test incorrectly indicates the presence of opioids.
If you need to undergo an opioid test, inform the healthcare professional administering the test that you are taking Lybalvi. They will utilize a different type of test for detecting opioids.
Lybalvi and Smoking
Inform your doctor if you smoke before starting Lybalvi. Smoking may cause your body to expel Lybalvi faster than usual, decreasing its effectiveness. Discuss the best dosage of Lybalvi and the best treatment plan with your doctor.
Lybalvi use with other drugs
In some instances, your doctor may advise combining Lybalvi with other medications to treat your condition. For example, individuals with bipolar I disorder might take Lybalvi along with lithium (Lithobid) or valproate, according to recommendations.
If you're interested in taking Lybalvi alongside other medications for your schizophrenia or bipolar I disorder, talk to your doctor. They can recommend the best treatment plan for you.
Lybalvi and alcohol
Although alcohol is not known to interact with Lybalvi, it can increase the risk of side effects such as orthostatic hypotension, potentially causing fainting or dizziness. Due to this risk, it’s recommended to avoid drinking alcohol or exercise caution when drinking alcohol if you’re taking Lybalvi.
If you consume alcohol, consult your doctor about how much alcohol, if any, is safe for you to drink during your Lybalvi treatment.
How to take Lybalvi
Take Lybalvi as directed by your doctor.
When to take
Take Lybalvi once daily, around the same time each day.
To help ensure that you do not miss a dose, consider using a medication reminder. This can include setting an alarm or using a timer. Alternatively, you could download a reminder app on your phone.
Certain pharmacies provide medication labels that feature larger text, braille, or a code for scanning with a smartphone, which converts text into speech. If your local pharmacy doesn't offer these options, your doctor or pharmacist might guide you to one that does.
If you encounter issues in opening medication containers, approach your pharmacist about obtaining Lybalvi in an easy-to-open container. They may also advise you on suitable tools to simplify the process of opening lids.
Consuming Lybalvi with meals
You can decide to ingest Lybalvi with or without food.
Can Lybalvi be split, crushed, or chewed?
It's recommended to swallow Lybalvi tablets whole. You should avoid crushing, splitting, or chewing Lybalvi.
Lybalvi and pregnancy
The safety of Lybalvi during pregnancy remains unclear.
Assuming pregnancy during the third trimester, Lybalvi intake can escalate the risk of withdrawal symptoms or extrapyramidal symptoms (uncontrolled body movements), such as agitation, tremors, or drowsiness, appearing in a newborn.
Research exploring individuals who took olanzapine, one of Lybalvi's components, doesn't indicate increased occurrence of congenital anomalies (generally referred to as "birth defects"). However, it is unclear what impact samidorphan (Lybalvi's other component) or the Lybalvi combination might have on a fetus.
Animal studies involving high doses of Lybalvi have been linked to fetal developmental problems. Nonetheless, animal studies don't necessarily forecast how humans will be affected.
It's also worth emphasizing that untreated bipolar I disorder or schizophrenia during pregnancy may elevate the risk of worsening symptoms, hospitalization, or even suicide.
If you're pregnant, expectant, or planning pregnancy, engage in a discussion about the most optimal treatment strategy for your bipolar I disorder or schizophrenia with your doctor.
Assistance is available
If you or someone you know is grappling with thoughts of suicide or self-harm, seek help:
- Dial or text the 988 Lifeline at 988 or visit 988lifeline.org for complimentary, confidential support round-the-clock. Caring counselors are available to listen to your concerns.
- Text "HOME" to the Crisis Text Line at 741741 to communicate with a volunteer counselor for free, confidential support 24/7.
- Search for a helpline in your country on Befrienders Worldwide.
- Dial 911 or your local emergency services number if you feel it's safe to do so.
If you're contacting on behalf of someone else, remain with them until help arrives. Safety measures such as removing harmful objects or substances may be implemented if feasible.
If you're not in the same residence, remain on the line with them until help arrives.
Lybalvi pregnancy registry
You might consider registering for Lybalvi's pregnancy registry if you utilize Lybalvi during pregnancy. A pregnancy registry gathers information about a drug's impact on pregnancy. Researchers evaluate the data to establish whether the drug is a suitable alternative during pregnancy.
For more details about this pregnancy registry or to enroll, check out the registration site or call 866-961-2388.
Lybalvi and fertility
Temporary reduction in female fertility is a possibility when utilizing Lybalvi.* However, your fertility will likely return to pre-Lybalvi treatment levels once you discontinue the medication. If you're planning to become pregnant, consult your doctor before initiating Lybalvi therapy.
Lybalvi did not appear to negatively impact male* fertility.
* Sex and gender are represented on spectrums. Here, "female" and "male" references tentatively assigned sexes.
Lybalvi and birth control
It's unknown whether Lybalvi is safe for use during pregnancy. If you're sexually active and both you and your partner can conceive, engage in conversations with your doctor about your birth control needs while using Lybalvi.
For more information about using Lybalvi during pregnancy, refer to the "Lybalvi and pregnancy" section above.
Lybalvi and breastfeeding
Breastfeeding while using Lybalvi might expose your baby to Lybalvi. Olanzapine, one of Lybalvi's components, does transit into breast milk. However, it's unclear whether samidorphan, Lybalvi's other component, is transferred through breast milk.
Babies fed breast milk containing olanzapine might display side effects such as drowsiness, fussiness, or difficulties in feeding. Extrapyramidal symptoms (movements over which a person lacks control), including tremors or uncontrolled muscle movements, might also manifest in babies exposed to Lybalvi through breastfeeding. Monitoring for these symptoms is advisable for children exposed to Lybalvi through breastfeeding.
If you're breastfeeding or considering breastfeeding, consult your doctor regarding Lybalvi's potential risks and benefits during breastfeeding.
Lybalvi carries a serious warning for an elevated risk of mortality in elderly individuals with psychosis linked to dementia (a condition marked by memory loss). This caution applies to all antipsychotic medications, including Lybalvi. This increased risk may cause your doctor to refrain from prescribing Lybalvi if you have dementia-related psychosis. For additional insight, refer to the "Lybalvi side effects" section detailed earlier.
Other Precautions
Before starting Lybalvi, share your medical background with your doctor. You may not be a suitable candidate for Lybalvi if you have certain medical conditions or other contributing factors to your health. These conditions include:
- Cardiovascular issues or stroke history: Previous heart problems or a history of strokes could require your doctor to prescribe an alternative medication due to increased heart-related risks associated with Lybalvi.
- Blood pressure concerns: Disclose any high or low blood pressure issues to your doctor before starting Lybalvi. The medication may alter your blood pressure and exacerbate existing conditions, necessitating closer blood pressure monitoring throughout treatment.
- Renal problems: Should you have severe kidney problems, bring this to your doctor's attention before beginning treatment with Lybalvi. Your kidneys play a crucial role in metabolizing this drug. With kidney dysfunction, excess Lybalvi may accumulate in your body, potentially leading to complications. Your doctor can assess whether Lybalvi is compatible with your kidney disorder.
- Diabetes: Diabetics should inform their doctors before using Lybalvi, as the drug could further raise blood sugar levels and exacerbate diabetes side effects. Your healthcare professional may suggest closer monitoring of blood sugar levels during treatment.
- High cholesterol or triglycerides: Lybalvi may contribute to increases in cholesterol and triglyceride levels. If you already have these conditions, Lybalvi may intensify these issues. Your physician may monitor these measurements during treatment to maintain optimal cholesterol and triglyceride levels.
- White blood cell deficiency: Lybalvi may lead to drop-in white blood cell levels. If you already suffer from white blood cell deficiency, Lybalvi could exacerbate the condition, potentially increasing your susceptibility to infections. Confer with your physician to determine whether Lybalvi is a suitable treatment option.
- Elevated prolactin levels: Lybalvi may boost prolactin levels. If you already have excessive prolactin levels, using this medication could worsen symptoms. Speak with your doctor regarding the potential risks and benefits of Lybalvi as a treatment option.
- Breast cancer: Certain breast cancer types may respond adverse to the hormone prolactin. Prolactin levels may increase with Lybalvi use. If you have breast cancer or a history of breast cancer, your doctor may advise against using this medication.
- Swallowing difficulties: Lybalvi could cause swallowing difficulty. Patients with existing swallowing problems may worsen with Lybalvi use. Your physician can help determine whether to prescribe Lybalvi considering your swallowing ability.
- Seizures: Lybalvi might elevate your risk of experiencing seizures. If you have a history of seizures or seizure disorders, inform your doctor before starting Lybalvi.
- Urinary retention: Usage of Lybalvi may increase the possibility of developing urinary retention. This may make urination difficulty. If you have urinary retention, your symptoms may worsen with Lybalvi use. Explore whether the medication is a suitable treatment option with your doctor.
- Prostate issues: Certain prostate problems may worsen if you use Lybalvi. You should consult your physician regarding the compatibility of this drug with your specific prostate concerns.
- Digestive issues: Libalvi use can heighten the risk of certain digestive problems, including constipation and paralytic ileus. If you have existing digestive issues, these symptoms may worsen under treatment. Check with your doctor to see whether Lybalvi is a suitable option for you.
- Falls risk: Lybalvi can augment the likelihood of falls. Patients with a predisposition to falls may experience further increased risk with Lybalvi use. Your doctor will assess your risk of falls prior to initiating treatment and periodically throughout treatment.
- Allergic reactions: An allergic reaction to Lybalvi or its components will likely preclude its prescription. Your doctor can guide you toward safe alternative options.
- Pregnancy: It is currently unclear whether Lybalvi is safe during pregnancy. For comprehensive information, see the "Lybalvi and pregnancy" section detailed earlier.
- Breastfeeding: Lybalvi's impact on breastfeeding is unknown. See the "Lybalvi and breastfeeding" section for further details.
Note: For a thorough understanding of Lybalvi's negative repercussions, examine the "Lybalvi side effects" section provided earlier.
Exceeding the prescribed dosage of Lybalvi can lead to significant health issues.
It's crucial not to exceed the amount of Lybalvi your doctor recommends.
Overdose signs
Signs of an overdose might include:
- restlessness or aggressive behavior
- elevated heartbeat
- fainting
- speech difficulties
- cardiovascular problems
- fluctuations in blood pressure
What to do in case of overdose
If you suspect you've consumed an excessive amount of this medication, contact your doctor immediately. Also, consider reaching out to America's Poison Control Centers at 800-222-1222, or utilize its online tool. However, if your symptoms are severe, dial 911 or your local emergency number, or visit the nearest emergency room promptly.
Lybalvi shelf life, storage, and disposal
Upon receiving Lybalvi from the pharmacy, the pharmacist will affix an expiration date to the medication bottle's label. This date usually falls a year after the drug was dispensed.
The expiration date ensures the medication's effectiveness within that timeframe. The Food and Drug Administration (FDA) advises against using expired medications. If you possess unused medication that surpasses the expiration date, discuss with your pharmacist about proper disposal methods.
Storage
A medication's longevity can be influenced by various factors, such as storage conditions.
Lybalvi tablets should be kept at room temperature (25°C/77°F). If necessary, Lybalvi can be stored between 15°C to 30°C (59°F to 86°F) for a brief duration. Keep the medication in its original pharmacy container, ensuring it's tightly sealed. Avoid storing Lybalvi in damp or wet areas, such as bathrooms.
Disposal
If you no longer need Lybalvi and have leftover medication, disposing of it safely is essential. This prevents accidental usage by children, pets, or others, and protects the environment.
This article provides valuable suggestions for medication disposal. You can also consult your pharmacist regarding disposal methods for your medication.
Medical News Today's Disclaimer: Medical News Today has taken all necessary measures to ensure the information presented is factually correct, exhaustive, and up-to-date. However, this article should not be used as a substitute for a healthcare professional's knowledge and expertise. Always consult with your doctor before taking any medication. The provided drug information is subject to change and does not cover all potential uses, directions, cautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not imply it's safe, effective, or appropriate for all patients or uses.
- The medication Lybalvi is often prescribed for individuals suffering from schizophrenia and bipolar I disorder, both of which are related to mental health.
- It's essential for individuals with depression to seek professional help, as they may benefit from medication like Lybalvi, which can potentially improve their symptoms.
- While taking Lybalvi, people may experience side effects, including weight gain, dry mouth, headache, and constipation, which can be managed with guidance from medical professionals.
- Pharmacists play a significant role in providing advice to individuals taking Lybalvi, helping them understand potential side effects and how to manage them, as well as offering assistance with any concerns related to the medication.
