Mavenclad 10mg Tabs (5) Pak
WARNING: This drug may lower the ability of the bone marrow to make blood cells that the body needs. If blood cell counts get very low, this can lead to bleeding problems, infections, or anemia. If you have questions, talk with the doctor.This drug may raise the risk of cancer. Do not take this drug to treat MS if you have cancer. If you have a risk for cancer or have ever had cancer, talk with your doctor.This drug may cause harm to the unborn baby if you take it while pregnant. Do not take this drug if you are pregnant, or if you are able to get pregnant but are not using birth control.If you are able to get pregnant, a pregnancy test will be done to show that you are NOT pregnant before starting this drug. Talk with your doctor.If you or your sex partner may become pregnant, you must use birth control while taking this drug and for 6 months after the last dose. Ask your doctor how long to use birth control and what kind of birth control to use. If you or your sex partner gets pregnant while taking this drug or within 6 months after stopping it, call the doctor right away. @ COMMON USES: It is used to treat MS (multiple sclerosis).
Drug Class
Immunosuppressant
Pharmacologic Class
Purine antimetabolite; Selective lymphocyte depletor
Pregnancy Category
Category X
FDA Approved
Mar 2019
DEA Schedule
Not Controlled
Overview
What is this medicine?
Mavenclad is a medication used to treat certain forms of multiple sclerosis (MS). It works by reducing the number of specific white blood cells (lymphocytes) that are involved in the immune system's attack on nerve cells in MS. This helps to reduce MS relapses and slow down the progression of the disease. It is given in two short treatment courses over two years.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most out of your medication, follow these steps:
Take your medication exactly as directed by your doctor. Read all the information provided with your prescription and follow the instructions carefully.
You can take your medication with or without food. Swallow the tablet whole with a glass of water. Do not chew or crush the tablet.
If you take other oral medications, take them at least 3 hours before or 3 hours after taking this medication. If this is not possible, consult your doctor for guidance.
Handling your medication requires special care. Consult your doctor or pharmacist for instructions on how to handle the medication safely.
Handling and Storage
Do not remove the medication from its blister pack until you are ready to take it. Take the medication immediately after opening the blister pack, and do not store the removed tablet for later use.
Make sure your hands are dry before touching the medication. Wash your hands after handling the medication.
Storing and Disposing of Your Medication
Store your medication in its original container at room temperature, in a dry place. Avoid storing it in a bathroom.
Keep all medications in a safe place, out of the reach of children and pets.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember on the same day. If you don't remember until the next day, take the missed dose and then take your next dose the day after. This will extend your treatment week by one day.
Do not take two doses at the same time or take extra doses to make up for a missed dose.
To ensure you get the most out of your medication, follow these steps:
Take your medication exactly as directed by your doctor. Read all the information provided with your prescription and follow the instructions carefully.
You can take your medication with or without food. Swallow the tablet whole with a glass of water. Do not chew or crush the tablet.
If you take other oral medications, take them at least 3 hours before or 3 hours after taking this medication. If this is not possible, consult your doctor for guidance.
Handling your medication requires special care. Consult your doctor or pharmacist for instructions on how to handle the medication safely.
Handling and Storage
Do not remove the medication from its blister pack until you are ready to take it. Take the medication immediately after opening the blister pack, and do not store the removed tablet for later use.
Make sure your hands are dry before touching the medication. Wash your hands after handling the medication.
Storing and Disposing of Your Medication
Store your medication in its original container at room temperature, in a dry place. Avoid storing it in a bathroom.
Keep all medications in a safe place, out of the reach of children and pets.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember on the same day. If you don't remember until the next day, take the missed dose and then take your next dose the day after. This will extend your treatment week by one day.
Do not take two doses at the same time or take extra doses to make up for a missed dose.
Lifestyle & Tips
- Use effective contraception during treatment and for at least 6 months after the last dose in each treatment year for both men and women.
- Avoid live or live-attenuated vaccines during treatment and until your doctor confirms your immune system has recovered (usually 4-6 weeks after the last dose).
- Report any signs of infection (fever, chills, sore throat, unusual fatigue, skin rash) immediately to your doctor.
- Report any new or worsening lumps, growths, or unexplained symptoms to your doctor, as there is an increased risk of cancer.
- Stay hydrated and maintain good hygiene to reduce infection risk.
- Avoid close contact with people who are sick or have recently received live vaccines.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Two treatment courses over 2 years. Each course consists of 2 treatment cycles. Each treatment cycle consists of 10 mg (one 10 mg tablet or two 10 mg tablets) taken once daily for 4 or 5 consecutive days. The total cumulative dose over 2 years is 3.5 mg/kg.
Condition-Specific Dosing:
Multiple Sclerosis (Relapsing Forms):
The recommended cumulative dose is 3.5 mg/kg over 2 years, administered as 1.75 mg/kg per year. Each annual treatment course is divided into 2 treatment cycles (e.g., Cycle 1 at Month 1 and Cycle 2 at Month 2 of Year 1; Cycle 3 at Month 13 and Cycle 4 at Month 14 of Year 2). Each treatment cycle consists of 10 mg (one 10 mg tablet or two 10 mg tablets) taken once daily for 4 or 5 consecutive days, depending on the patient's weight.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment required (CrCl 60-89 mL/min).
Moderate:
Contraindicated (CrCl 30-59 mL/min).
Severe:
Contraindicated (CrCl <30 mL/min).
Dialysis:
Contraindicated. Not studied.
Hepatic Impairment:
Mild:
No dose adjustment required.
Moderate:
No dose adjustment required.
Severe:
No dose adjustment required. Caution advised due to limited data.
Pharmacology
Mechanism of Action
Cladribine is a purine nucleoside analog. It is a prodrug that is phosphorylated intracellularly by deoxycytidine kinase (DCK) to its active triphosphate form, 2-chloro-2'-deoxyadenosine triphosphate (Cd-ATP). Cd-ATP is incorporated into DNA, leading to DNA strand breaks and inhibition of DNA synthesis and repair. This results in the depletion of rapidly dividing cells, particularly lymphocytes (B and T cells), which have high levels of DCK and low levels of 5'-nucleotidase (which deactivates Cd-AMP). The selective and sustained reduction of lymphocytes is thought to be the primary mechanism by which cladribine exerts its therapeutic effects in multiple sclerosis.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 40% (oral)
Tmax:
0.5 to 1.5 hours
FoodEffect:
Food does not significantly affect absorption.
Distribution:
Vd:
Approximately 490-980 L (high volume of distribution)
ProteinBinding:
Approximately 20%
CnssPenetration:
Limited (CSF concentrations are approximately 25% of plasma concentrations)
Elimination:
HalfLife:
Approximately 24 hours (terminal plasma half-life)
Clearance:
Approximately 22-29 L/hr (renal and non-renal)
ExcretionRoute:
Renal (approximately 50% of dose excreted unchanged in urine)
Unchanged:
Approximately 50%
Pharmacodynamics
OnsetOfAction:
Lymphocyte count reduction begins within days of administration.
PeakEffect:
Maximum lymphocyte reduction typically occurs 2-3 months after each treatment course.
DurationOfAction:
Sustained lymphocyte reduction for up to 6 months after each course, with immune reconstitution over 6-12 months. Clinical efficacy extends for at least 2 years after the last dose.
Safety & Warnings
BLACK BOX WARNING
MALIGNANCY and TERATOGENICITY. MAVENCLAD may increase the risk of malignancy. MAVENCLAD is contraindicated in patients with active malignancy. MAVENCLAD may cause fetal harm when administered to a pregnant woman. MAVENCLAD is contraindicated in pregnant women and in women and men of reproductive potential who do not plan to use effective contraception during and after treatment.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Allergic Reaction: Rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Infection: Fever, chills, severe sore throat, ear or sinus pain, cough, increased or discolored sputum, painful urination, mouth sores, or a wound that won't heal.
Shingles: Pain, itching, or tingling, fever, muscle aches, or a rash (with or without blisters).
Bleeding: Vomiting or coughing up blood, coffee ground-like vomit, blood in the urine, black, red, or tarry stools, gum bleeding, abnormal vaginal bleeding, unexplained bruises or bruises that enlarge, or uncontrollable bleeding.
Severe Skin Reaction (Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis): Red, swollen, blistered, or peeling skin (with or without fever), red or irritated eyes, or sores in the mouth, throat, nose, or eyes.
Other Serious Symptoms: Extreme fatigue or weakness, shortness of breath, sudden weight gain, or swelling in the arms or legs, rapid or irregular heartbeat, severe headache or dizziness, fainting, or changes in vision.
Depression: Mood changes, loss of interest in activities, or changes in appetite or sleep patterns.
Progressive Multifocal Leukoencephalopathy (PML): A rare and potentially fatal brain condition. Seek medical help immediately if you experience confusion, memory problems, depression, changes in behavior, uneven strength, difficulty speaking or thinking, balance problems, or vision changes.
Liver Problems: Sometimes life-threatening, liver problems may cause dark urine, fatigue, decreased appetite, nausea or stomach pain, light-colored stools, vomiting, or yellow skin or eyes. Contact your doctor right away if you notice any of these symptoms.
Other Possible Side Effects
Most people taking this medication will not experience severe side effects, but some may encounter mild or moderate symptoms. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Common cold symptoms
Upset stomach
Headache
Back pain
Joint pain
Difficulty sleeping
Hair thinning or loss
This is not an exhaustive list of possible side effects. If you have concerns or questions, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Allergic Reaction: Rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Infection: Fever, chills, severe sore throat, ear or sinus pain, cough, increased or discolored sputum, painful urination, mouth sores, or a wound that won't heal.
Shingles: Pain, itching, or tingling, fever, muscle aches, or a rash (with or without blisters).
Bleeding: Vomiting or coughing up blood, coffee ground-like vomit, blood in the urine, black, red, or tarry stools, gum bleeding, abnormal vaginal bleeding, unexplained bruises or bruises that enlarge, or uncontrollable bleeding.
Severe Skin Reaction (Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis): Red, swollen, blistered, or peeling skin (with or without fever), red or irritated eyes, or sores in the mouth, throat, nose, or eyes.
Other Serious Symptoms: Extreme fatigue or weakness, shortness of breath, sudden weight gain, or swelling in the arms or legs, rapid or irregular heartbeat, severe headache or dizziness, fainting, or changes in vision.
Depression: Mood changes, loss of interest in activities, or changes in appetite or sleep patterns.
Progressive Multifocal Leukoencephalopathy (PML): A rare and potentially fatal brain condition. Seek medical help immediately if you experience confusion, memory problems, depression, changes in behavior, uneven strength, difficulty speaking or thinking, balance problems, or vision changes.
Liver Problems: Sometimes life-threatening, liver problems may cause dark urine, fatigue, decreased appetite, nausea or stomach pain, light-colored stools, vomiting, or yellow skin or eyes. Contact your doctor right away if you notice any of these symptoms.
Other Possible Side Effects
Most people taking this medication will not experience severe side effects, but some may encounter mild or moderate symptoms. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Common cold symptoms
Upset stomach
Headache
Back pain
Joint pain
Difficulty sleeping
Hair thinning or loss
This is not an exhaustive list of possible side effects. If you have concerns or questions, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Fever, chills, body aches, sore throat, cough, or other signs of infection.
- New or worsening skin lesions, lumps, or growths.
- Unexplained weight loss or persistent fatigue.
- Yellowing of skin or eyes (jaundice), dark urine, severe stomach pain, nausea, or vomiting (signs of liver problems).
- Severe headache, confusion, seizures, or vision changes (signs of PML, though rare).
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction you experienced, including the symptoms that occurred.
Existing health conditions, including kidney disease or liver disease.
Infections such as hepatitis B, hepatitis C, HIV, or tuberculosis (TB).
Any medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, as some may interact with this medication. Specifically, certain drugs used to treat hepatitis C, HIV, and infections should not be taken with this medication.
A diagnosis of clinically isolated syndrome (CIS), a condition that affects the central nervous system.
If you are breast-feeding or plan to breast-feed. It is recommended that you do not breast-feed while taking this medication, and you may need to avoid breast-feeding for a period after your last dose. Consult your doctor to determine the necessary precautions.
This list is not exhaustive, and it is crucial to discuss all your medications, health problems, and concerns with your doctor and pharmacist to ensure safe use. Do not start, stop, or modify the dosage of any medication without consulting your doctor first.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction you experienced, including the symptoms that occurred.
Existing health conditions, including kidney disease or liver disease.
Infections such as hepatitis B, hepatitis C, HIV, or tuberculosis (TB).
Any medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, as some may interact with this medication. Specifically, certain drugs used to treat hepatitis C, HIV, and infections should not be taken with this medication.
A diagnosis of clinically isolated syndrome (CIS), a condition that affects the central nervous system.
If you are breast-feeding or plan to breast-feed. It is recommended that you do not breast-feed while taking this medication, and you may need to avoid breast-feeding for a period after your last dose. Consult your doctor to determine the necessary precautions.
This list is not exhaustive, and it is crucial to discuss all your medications, health problems, and concerns with your doctor and pharmacist to ensure safe use. Do not start, stop, or modify the dosage of any medication without consulting your doctor first.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
While taking this drug, you may be at a higher risk of developing infections, some of which can be severe or even life-threatening. To minimize this risk, practice good hygiene by washing your hands frequently and avoid close contact with individuals who have infections, colds, or flu.
Additionally, this medication may increase your likelihood of bleeding easily. To reduce the risk of injury, exercise caution in your daily activities and use a soft toothbrush and an electric razor for personal grooming.
Regular monitoring of your blood work and other laboratory tests is crucial, as directed by your doctor. If you are not up to date with all recommended vaccinations, consult with your doctor, as you may need to receive certain vaccines before starting treatment with this drug.
Before receiving any vaccinations, discuss the potential risks and benefits with your doctor, as some vaccines may not be effective or may increase the risk of infection when used in conjunction with this medication.
If you have taken this drug and are scheduled to receive a blood transfusion, inform your doctor, as they may order an MRI scan before initiating treatment.
There is a risk of developing herpes zoster (shingles) while taking this medication. Consult with your doctor to determine if a vaccine is necessary before starting treatment.
Furthermore, cases of hepatitis and tuberculosis (TB) have been reported in patients taking this drug, and in some instances, these conditions have been fatal. As a precautionary measure, you will undergo testing for hepatitis and TB before the first and second treatment courses to assess your risk.
While taking this drug, you may be at a higher risk of developing infections, some of which can be severe or even life-threatening. To minimize this risk, practice good hygiene by washing your hands frequently and avoid close contact with individuals who have infections, colds, or flu.
Additionally, this medication may increase your likelihood of bleeding easily. To reduce the risk of injury, exercise caution in your daily activities and use a soft toothbrush and an electric razor for personal grooming.
Regular monitoring of your blood work and other laboratory tests is crucial, as directed by your doctor. If you are not up to date with all recommended vaccinations, consult with your doctor, as you may need to receive certain vaccines before starting treatment with this drug.
Before receiving any vaccinations, discuss the potential risks and benefits with your doctor, as some vaccines may not be effective or may increase the risk of infection when used in conjunction with this medication.
If you have taken this drug and are scheduled to receive a blood transfusion, inform your doctor, as they may order an MRI scan before initiating treatment.
There is a risk of developing herpes zoster (shingles) while taking this medication. Consult with your doctor to determine if a vaccine is necessary before starting treatment.
Furthermore, cases of hepatitis and tuberculosis (TB) have been reported in patients taking this drug, and in some instances, these conditions have been fatal. As a precautionary measure, you will undergo testing for hepatitis and TB before the first and second treatment courses to assess your risk.
Overdose Information
Overdose Symptoms:
- Severe myelosuppression (bone marrow suppression), leading to profound lymphopenia, neutropenia, and anemia.
- Increased risk of severe infections.
What to Do:
There is no specific antidote. Management involves supportive care, including close monitoring of hematologic parameters, anti-infective therapy if needed, and potentially blood transfusions. Call 1-800-222-1222 (Poison Control) or seek immediate medical attention.
Drug Interactions
Contraindicated Interactions
- Live or live-attenuated vaccines (during and after treatment until lymphocyte counts recover)
- Other immunosuppressants (e.g., methotrexate, cyclosporine, azathioprine) - concurrent use is not recommended due to risk of additive immunosuppression.
- Chronic or acute infections (e.g., HIV, active tuberculosis, hepatitis)
Major Interactions
- Bone marrow suppressants (e.g., carbamazepine, chloramphenicol, clozapine, interferon beta, natalizumab, ocrelizumab, teriflunomide) - increased risk of myelosuppression.
- Nephrotoxic drugs (e.g., aminoglycosides, NSAIDs) - caution due to renal elimination.
- Drugs that affect lymphocyte counts (e.g., corticosteroids, other MS therapies)
Moderate Interactions
- Strong BCRP (Breast Cancer Resistance Protein) inhibitors (e.g., eltrombopag, cyclosporine, gefitinib, lapatinib, pantoprazole, rabeprazole) - may increase cladribine exposure.
- Strong BCRP inducers (e.g., rifampin, St. John's Wort) - may decrease cladribine exposure.
- Nucleoside transport inhibitors (e.g., dilazep, nifedipine, nimodipine, reserpine, verapamil) - may affect intracellular uptake of cladribine.
Minor Interactions
- Not specifically identified, but general caution with drugs affecting immune system.
Monitoring
Baseline Monitoring
Complete Blood Count (CBC) with differential
Rationale: To establish baseline lymphocyte count and identify pre-existing cytopenias. Lymphocyte count must be ≥ 800 cells/mm³.
Timing: Within 6 weeks prior to the first treatment cycle of Year 1 and Year 2.
Varicella Zoster Virus (VZV) serology
Rationale: To assess immunity to VZV. Patients seronegative for VZV should be vaccinated prior to treatment.
Timing: Prior to initiation of treatment.
Tuberculosis (TB) screening
Rationale: To rule out active or latent TB infection.
Timing: Prior to initiation of treatment.
Liver function tests (LFTs)
Rationale: To assess baseline hepatic function.
Timing: Prior to initiation of treatment.
Malignancy screening
Rationale: To assess for pre-existing malignancies, as cladribine carries a risk of malignancy.
Timing: Prior to initiation of treatment.
Pregnancy test
Rationale: To rule out pregnancy in females of reproductive potential.
Timing: Within 6 weeks prior to the first treatment cycle of Year 1 and Year 2.
Routine Monitoring
Complete Blood Count (CBC) with differential
Frequency: Before each treatment cycle (Month 1 and Month 2 of Year 1; Month 13 and Month 14 of Year 2), and at Month 3 and Month 6 after the start of each treatment course (Year 1 and Year 2).
Target: Lymphocyte count ≥ 500 cells/mm³ for subsequent cycles/courses.
Action Threshold: If lymphocyte count < 500 cells/mm³, delay treatment until count recovers. If count < 200 cells/mm³, consider antiviral prophylaxis.
Signs and symptoms of infection
Frequency: Ongoing throughout treatment and follow-up.
Target: Absence of fever, chills, malaise, localized infection signs.
Action Threshold: Prompt evaluation and management of any suspected infection.
Signs and symptoms of malignancy
Frequency: Ongoing throughout treatment and follow-up.
Target: Absence of new or worsening symptoms.
Action Threshold: Prompt evaluation of any suspicious findings.
Symptom Monitoring
- Signs of infection (fever, chills, sore throat, cough, unusual fatigue, skin lesions, urinary symptoms)
- Signs of malignancy (unexplained weight loss, persistent fatigue, new lumps or growths, changes in moles, persistent cough, unusual bleeding)
- Signs of liver injury (jaundice, dark urine, abdominal pain, nausea, vomiting)
Special Patient Groups
Pregnancy
Contraindicated. Cladribine can cause fetal harm. Females of reproductive potential must use effective contraception during treatment and for at least 6 months after the last dose in each treatment year. Males of reproductive potential must use effective contraception during treatment and for at least 6 months after the last dose in each treatment year.
Trimester-Specific Risks:
First Trimester:
High risk of teratogenicity and fetal harm due to interference with DNA synthesis.
Second Trimester:
High risk of fetal harm.
Third Trimester:
High risk of fetal harm.
Lactation
Contraindicated. It is unknown if cladribine is excreted in human milk. Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is contraindicated during treatment and for 10 days after the last dose in each treatment year.
Infant Risk:
High risk of serious adverse effects, including immunosuppression and bone marrow suppression.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Not recommended for use in patients under 18 years of age.
Geriatric Use
Use with caution in patients 65 years of age and older due to increased risk of serious infections and malignancies. Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. No specific dose adjustment is recommended based on age alone, but careful monitoring is warranted.
Clinical Information
Clinical Pearls
- Mavenclad is an oral therapy administered in two short treatment courses over two years, offering a unique dosing schedule compared to other MS therapies.
- Strict adherence to the monitoring schedule for lymphocyte counts is crucial to manage the risk of severe lymphopenia and associated infections.
- Patients must be screened for active infections (especially VZV and TB) and malignancy prior to initiation of treatment.
- Counsel patients extensively on the importance of contraception for both males and females during and for 6 months after treatment due to teratogenicity risk.
- Live vaccines are contraindicated during and after treatment until lymphocyte counts recover; advise patients to discuss vaccination plans with their healthcare provider.
- The long-lasting effect of cladribine means that patients do not receive continuous daily therapy, but the immune effects persist for an extended period.
Alternative Therapies
- Interferon beta (e.g., Avonex, Betaseron, Rebif, Extavia)
- Glatiramer acetate (e.g., Copaxone, Glatopa)
- Natalizumab (Tysabri)
- Fingolimod (Gilenya)
- Teriflunomide (Aubagio)
- Dimethyl fumarate (Tecfidera)
- Ocrelizumab (Ocrevus)
- Alemtuzumab (Lemtrada)
- Siponimod (Mayzent)
- Ozanimod (Zeposia)
- Ponesimod (Ponvory)
Cost & Coverage
Average Cost:
Highly variable, typically >$100,000 per treatment course per 30 tablets (approximate, as dosing is weight-based and packaged differently)
Insurance Coverage:
Specialty Tier (requires prior authorization, step therapy, and often a limited distribution network)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to consult with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to consult with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.