Mavenclad 10mg Tabs (10)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
Disease-modifying therapy (DMT) for Multiple Sclerosis
Pharmacologic Class
Purine antimetabolite; Selective immunosuppressant
Pregnancy Category
Category X
FDA Approved
Mar 2019
DEA Schedule
Not Controlled
Overview
What is this medicine?
Mavenclad is a medication taken by mouth for multiple sclerosis (MS). It works by temporarily reducing certain types of white blood cells (lymphocytes) that are involved in MS, helping to reduce flare-ups and slow down the progression of the disease. It's given in two short treatment courses over two years, with no further treatment needed for the following two years.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication 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
When handling your medication, take the following precautions:
Check with your doctor or pharmacist for specific instructions on how to handle your medication.
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. Do not store the removed medication 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
To store your medication properly:
Keep it in its original container at room temperature.
Store it in a dry place, away from the 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, follow these steps:
Take the missed dose 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.
Do not take two doses at the same time or take extra doses.
To ensure you get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication 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
When handling your medication, take the following precautions:
Check with your doctor or pharmacist for specific instructions on how to handle your medication.
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. Do not store the removed medication 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
To store your medication properly:
Keep it in its original container at room temperature.
Store it in a dry place, away from the 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, follow these steps:
Take the missed dose 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.
Do not take two doses at the same time or take extra doses.
Lifestyle & Tips
- Use effective contraception during treatment and for at least 6 months after the last dose of each treatment course (for both men and women).
- Avoid live or attenuated live vaccines during and after treatment as advised by your doctor.
- Report any signs of infection (fever, chills, sore throat, unusual fatigue) immediately.
- Report any new or worsening lumps, persistent cough, or unexplained weight loss.
- Do not take other immunosuppressants or myelosuppressive drugs without consulting your doctor.
- Stay hydrated and maintain good hygiene to reduce infection risk.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Total cumulative dose of 3.5 mg/kg (over 2 years) administered as 1.75 mg/kg per year. Each annual dose is divided into 2 treatment courses, approximately 4-5 weeks apart. Each course consists of 4-5 consecutive days of daily dosing (10 mg or 14 mg depending on weight).
Condition-Specific Dosing:
Multiple Sclerosis (MS):
For patients with relapsing-remitting MS (RRMS) and active secondary progressive MS (SPMS). Dosing is weight-based: 10 mg or 14 mg tablets daily for 4-5 days in Week 1, then again 4-5 weeks later for 4-5 days in Week 2. This constitutes Year 1 treatment. Year 2 treatment follows the same schedule, approximately 12 months after the first dose of Year 1. No further treatment is recommended for Years 3 and 4.
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 mL/min).
Moderate:
Contraindicated (CrCl <60 mL/min).
Severe:
Contraindicated (CrCl <30 mL/min).
Dialysis:
Not studied; contraindicated due to severe renal impairment.
Hepatic Impairment:
Mild:
No specific dose adjustment required.
Moderate:
No specific dose adjustment required, but caution is advised due to limited data.
Severe:
No specific dose adjustment required, but caution is advised due to limited data.
Pharmacology
Mechanism of Action
Cladribine 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 incorporates into DNA, leading to DNA strand breaks and inhibition of DNA synthesis and repair. Lymphocytes, particularly B and T cells, are highly susceptible to cladribine due to their high DCK to 5'-nucleotidase ratio, leading to selective depletion of these cells, which are thought to play a key role in the pathogenesis of MS.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 40% (oral)
Tmax:
0.5 to 1.5 hours
FoodEffect:
No clinically significant effect of food on absorption.
Distribution:
Vd:
490 to 980 L (large volume of distribution)
ProteinBinding:
Approximately 20%
CnssPenetration:
Yes, cladribine crosses the blood-brain barrier, with CSF concentrations approximately 25% of plasma concentrations.
Elimination:
HalfLife:
Plasma terminal half-life: Approximately 24 hours; Intracellular half-life of Cd-ATP in lymphocytes is much longer (e.g., 15 hours in B cells, 10 hours in T cells).
Clearance:
Renal clearance is the primary route of elimination for unchanged drug.
ExcretionRoute:
Renal (primarily unchanged drug)
Unchanged:
Approximately 50% of the dose is excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
Lymphocyte count reduction typically begins within days to weeks.
PeakEffect:
Maximum lymphocyte reduction (nadir) typically occurs 2-3 months after the last dose of each treatment course.
DurationOfAction:
The therapeutic effect is sustained due to prolonged lymphocyte depletion, with lymphocyte counts gradually recovering over 6-9 months, but remaining below baseline for up to 2 years or longer. No further treatment is recommended for Years 3 and 4 after the initial two-year course.
Safety & Warnings
BLACK BOX WARNING
MALIGNANCY: Mavenclad may increase the risk of malignancy. Patients with a current malignancy should not be treated with Mavenclad. Prior to initiating Mavenclad, patients should be screened for malignancy. Follow standard cancer screening guidelines in patients treated with Mavenclad. TERATOGENICITY: 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. Exclude pregnancy prior to initiation of Mavenclad in females of reproductive potential. Advise females of reproductive potential to use effective contraception during Mavenclad dosing and for at least 6 months after the last dose of each treatment course. Advise males of reproductive potential to use effective contraception during Mavenclad dosing and for at least 6 months after the last dose of each treatment course.
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, redness, swelling, blistering, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or speaking, 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 bruising that worsens, 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.
Extreme Fatigue or Weakness: Feeling very tired or weak.
Respiratory Issues: Shortness of breath, significant weight gain, or swelling in the arms or legs.
Cardiac Problems: Abnormal or rapid heartbeat.
High Blood Pressure: Severe headache, dizziness, fainting, or changes in vision.
Depression: Mood changes or feelings of sadness.
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, speech or thinking difficulties, balance problems, or vision changes.
Liver Problems: Sometimes life-threatening, liver issues may cause dark urine, fatigue, decreased appetite, stomach pain or upset, light-colored stools, vomiting, or yellow skin and eyes. Contact your doctor right away if you notice any of these symptoms.
Other Possible Side Effects
While many people may not experience side effects or only have mild ones, it's essential to be aware of the following:
Common cold symptoms
Upset stomach
Headache
Back pain
Joint pain
Sleep disturbances
* Hair thinning or loss
If any of these side effects or other concerns bother you or persist, contact your doctor for guidance. This is not an exhaustive list of possible side effects. If you have questions or concerns, don't hesitate to reach out to your doctor.
Reporting Side Effects
You can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor is also available to provide medical advice and guidance on managing side effects.
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, redness, swelling, blistering, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or speaking, 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 bruising that worsens, 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.
Extreme Fatigue or Weakness: Feeling very tired or weak.
Respiratory Issues: Shortness of breath, significant weight gain, or swelling in the arms or legs.
Cardiac Problems: Abnormal or rapid heartbeat.
High Blood Pressure: Severe headache, dizziness, fainting, or changes in vision.
Depression: Mood changes or feelings of sadness.
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, speech or thinking difficulties, balance problems, or vision changes.
Liver Problems: Sometimes life-threatening, liver issues may cause dark urine, fatigue, decreased appetite, stomach pain or upset, light-colored stools, vomiting, or yellow skin and eyes. Contact your doctor right away if you notice any of these symptoms.
Other Possible Side Effects
While many people may not experience side effects or only have mild ones, it's essential to be aware of the following:
Common cold symptoms
Upset stomach
Headache
Back pain
Joint pain
Sleep disturbances
* Hair thinning or loss
If any of these side effects or other concerns bother you or persist, contact your doctor for guidance. This is not an exhaustive list of possible side effects. If you have questions or concerns, don't hesitate to reach out to your doctor.
Reporting Side Effects
You can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor is also available to provide medical advice and guidance on managing side effects.
Seek Immediate Medical Attention If You Experience:
- Signs of serious infection: fever, chills, body aches, persistent cough, shortness of breath, painful urination, skin rash, or sores.
- Signs of malignancy: new or growing lumps, unexplained weight loss, persistent cough, changes in moles.
- Signs of liver problems: yellowing of skin or eyes (jaundice), dark urine, severe stomach pain, unusual tiredness.
- Signs of Progressive Multifocal Leukoencephalopathy (PML): new or worsening weakness on one side of the body, clumsiness, vision changes, changes in thinking or memory, confusion, personality changes.
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. Be sure to describe the allergic reaction you experienced.
Existing health conditions, including kidney disease, liver disease, hepatitis B, hepatitis C, HIV, or other infections.
If you have been diagnosed with 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 may be contraindicated.
If you have been diagnosed with clinically isolated syndrome (CIS).
If you are breastfeeding or plan to breastfeed. Note that breastfeeding is not recommended while taking this medication, and you may need to avoid breastfeeding for a period after your last dose. Consult your doctor to determine the necessary duration.
This list is not exhaustive, and it is crucial to discuss all your medications and health conditions with your doctor and pharmacist to ensure safe use. Do not initiate, discontinue, or modify any medication without first consulting your doctor to verify the safety of combining this medication with your other treatments and health conditions.
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. Be sure to describe the allergic reaction you experienced.
Existing health conditions, including kidney disease, liver disease, hepatitis B, hepatitis C, HIV, or other infections.
If you have been diagnosed with 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 may be contraindicated.
If you have been diagnosed with clinically isolated syndrome (CIS).
If you are breastfeeding or plan to breastfeed. Note that breastfeeding is not recommended while taking this medication, and you may need to avoid breastfeeding for a period after your last dose. Consult your doctor to determine the necessary duration.
This list is not exhaustive, and it is crucial to discuss all your medications and health conditions with your doctor and pharmacist to ensure safe use. Do not initiate, discontinue, or modify any medication without first consulting your doctor to verify the safety of combining this medication with your other treatments and health conditions.
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 tendency to bleed 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 your doctor to determine if any vaccines are necessary before starting treatment with this drug.
Before receiving any vaccinations, discuss the potential risks and benefits with your doctor, as certain 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 your doctor to determine if a vaccine is recommended 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 tendency to bleed 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 your doctor to determine if any vaccines are necessary before starting treatment with this drug.
Before receiving any vaccinations, discuss the potential risks and benefits with your doctor, as certain 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 your doctor to determine if a vaccine is recommended 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 severe lymphopenia, neutropenia, and anemia.
- Increased risk of infection.
What to Do:
There is no specific antidote for cladribine overdose. Treatment should consist of careful observation and supportive measures, including close monitoring of hematologic parameters and management of potential complications such as infection. Contact a poison control center (e.g., 1-800-222-1222) or seek emergency medical attention immediately.
Drug Interactions
Contraindicated Interactions
- Immunosuppressants (e.g., methotrexate, cyclosporine, azathioprine) - due to additive immunosuppressive effects and risk of severe myelosuppression.
- Live or attenuated live vaccines - due to risk of vaccine-induced infection.
Major Interactions
- Other myelosuppressive agents (e.g., interferon beta, natalizumab, mitoxantrone) - increased risk of hematologic toxicity.
- P-glycoprotein (P-gp) and Breast Cancer Resistance Protein (BCRP) inhibitors (e.g., cyclosporine, verapamil, ritonavir, eltrombopag) - may increase cladribine exposure.
- P-glycoprotein (P-gp) and Breast Cancer Resistance Protein (BCRP) inducers (e.g., rifampin, St. John's Wort) - may decrease cladribine exposure.
Moderate Interactions
- Nephrotoxic drugs - caution due to cladribine's renal elimination.
- Drugs that affect lymphocyte counts (e.g., corticosteroids) - potential additive effects on lymphocyte reduction.
Monitoring
Baseline Monitoring
Complete Blood Count (CBC) with differential (lymphocyte count)
Rationale: To ensure baseline lymphocyte count is within normal limits and to assess for pre-existing cytopenias. Lymphocyte count must be ≥800 cells/mm³.
Timing: Within 10 days prior to the first dose of each treatment course (Year 1 and Year 2).
Tuberculosis (TB) screening
Rationale: To rule out active or latent TB infection, as cladribine can increase risk of opportunistic infections.
Timing: Prior to initiation of Mavenclad.
Hepatitis B and C screening
Rationale: To rule out active infection, as cladribine can increase risk of reactivation.
Timing: Prior to initiation of Mavenclad.
Varicella Zoster Virus (VZV) antibody status
Rationale: To assess immunity; vaccination should be considered for VZV-seronegative patients prior to treatment.
Timing: Prior to initiation of Mavenclad.
Malignancy screening
Rationale: To assess for pre-existing malignancies, as cladribine carries a risk of malignancy.
Timing: Prior to initiation of Mavenclad and as clinically indicated.
Routine Monitoring
Complete Blood Count (CBC) with differential (lymphocyte count)
Frequency: Before each treatment course (Year 1 and Year 2), and at Months 2 and 6 of Year 1 and Year 2. Additional monitoring may be needed if lymphocyte counts are low.
Target: Lymphocyte count should be ≥800 cells/mm³ before starting each course. Nadir typically occurs 2-3 months after each course.
Action Threshold: If lymphocyte count is <500 cells/mm³ at Month 2 or 6, monitor until recovery. If severe lymphopenia (Grade 4, <200 cells/mm³) occurs, consider antiviral prophylaxis and delay subsequent doses until recovery.
Signs and symptoms of infection
Frequency: Regularly throughout treatment and for at least 6 months after the last dose.
Target: N/A
Action Threshold: Promptly evaluate and treat any signs of infection.
Signs and symptoms of malignancy
Frequency: Regularly throughout treatment and for at least 4 years after the last dose.
Target: N/A
Action Threshold: Promptly evaluate any suspicious findings.
Symptom Monitoring
- Signs of infection (fever, chills, sore throat, cough, unusual fatigue, skin lesions)
- Signs of malignancy (new or worsening lumps, persistent cough, unexplained weight loss, changes in moles)
- Signs of progressive multifocal leukoencephalopathy (PML) (new or worsening neurological symptoms, cognitive changes, visual disturbances)
Special Patient Groups
Pregnancy
Contraindicated in pregnant women. Cladribine can cause fetal harm. Females of reproductive potential must have a negative pregnancy test before starting treatment and use effective contraception during treatment and for at least 6 months after the last dose of each treatment course. Males of reproductive potential must also use effective contraception during treatment and for at least 6 months after the last dose of each treatment course.
Trimester-Specific Risks:
First Trimester:
High risk of teratogenicity and embryofetal toxicity due to its mechanism of action (DNA synthesis inhibition).
Second Trimester:
High risk of fetal harm.
Third Trimester:
High risk of fetal harm.
Lactation
Contraindicated during breastfeeding. Cladribine is excreted in human milk and has the potential for serious adverse reactions in breastfed infants. Women should not breastfeed during treatment and for at least 10 days after the last dose of each treatment course.
Infant Risk:
High risk of serious adverse effects due to immunosuppression and potential for DNA damage.
Pediatric Use
Safety and effectiveness in pediatric patients (under 18 years of age) have not been established. Use is not recommended.
Geriatric Use
Clinical studies did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. No specific dose adjustment is recommended based on age, but caution is advised due to potential for decreased renal function and increased susceptibility to infections in older adults.
Clinical Information
Clinical Pearls
- Mavenclad is a high-efficacy DMT for MS, but requires careful patient selection and monitoring due to its safety profile, particularly regarding malignancy and lymphopenia.
- The treatment regimen is unique: two short courses over two years, with no further treatment recommended for the subsequent two years, offering a 'pulsed' or 'rebaselining' approach.
- Strict adherence to contraception guidelines is crucial for both male and female patients of reproductive potential.
- Patients must be screened for active infections (TB, Hepatitis B/C, VZV) and malignancy prior to initiation.
- Lymphocyte counts are critical for monitoring; ensure counts are within acceptable limits before each treatment course and monitor closely afterwards for nadir and recovery.
- Educate patients thoroughly on signs of infection and malignancy, and the importance of reporting them promptly.
Alternative Therapies
- Interferon beta (e.g., Avonex, Betaseron, Rebif, Plegridy)
- Glatiramer acetate (e.g., Copaxone, Glatopa)
- Fingolimod (Gilenya)
- Natalizumab (Tysabri)
- Ocrelizumab (Ocrevus)
- Alemtuzumab (Lemtrada)
- Dimethyl fumarate (Tecfidera)
- Teriflunomide (Aubagio)
- Siponimod (Mayzent)
- Ozanimod (Zeposia)
- Ponesimod (Ponvory)
Cost & Coverage
Average Cost:
Highly variable, typically >$80,000 - $100,000+ per annual treatment course
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 is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which is a crucial patient fact sheet. Please read it carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, consult 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. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.