Mavenclad 10mg Tablets (4 Tab Pack)
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)
Pharmacologic Class
Purine nucleoside analog; Selective immunosuppressant
Pregnancy Category
Not available
FDA Approved
Mar 2019
DEA Schedule
Not Controlled
Overview
What is this medicine?
Mavenclad is a medication used to treat certain types 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 the body in MS. It's given in short courses over two years, and then no more treatment is typically needed for the next 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 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 make up for a missed dose. This will ensure your treatment schedule stays on track, although your treatment week may be extended by one day.
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 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 make up for a missed dose. This will ensure your treatment schedule stays on track, although your treatment week may be extended by one day.
Lifestyle & Tips
- Take Mavenclad exactly as prescribed by your doctor. Do not take more or less than instructed.
- Swallow tablets whole with water. Do not chew, crush, or break the tablets.
- Wash your hands thoroughly after handling the tablets.
- Avoid contact with pregnant women and women of childbearing potential when handling the tablets.
- Do not take other medications, including over-the-counter drugs, herbal remedies, or supplements, without consulting your doctor.
- Report any signs of infection (fever, chills, sore throat, unusual fatigue) immediately to your doctor.
- Avoid live or attenuated vaccines during and after treatment until your doctor advises it is safe.
- Use effective contraception during treatment and for at least 6 months after the last dose of Mavenclad for both males and females.
- Attend all scheduled blood tests and doctor appointments to monitor your lymphocyte counts and overall health.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
The recommended cumulative dose of Mavenclad is 3.5 mg/kg administered orally over 2 years, divided into 2 annual treatment courses. Each annual treatment course consists of 2 treatment cycles. Each treatment cycle consists of 4 or 5 days of dosing.
Condition-Specific Dosing:
Relapsing forms of Multiple Sclerosis (MS):
Administer as two annual treatment courses. Each annual treatment course consists of two treatment cycles. Each treatment cycle consists of 4 or 5 days of dosing at 10 mg or 20 mg per day. The total cumulative dose is 3.5 mg/kg over 2 years. The first treatment course (Year 1) is given as 1.75 mg/kg, divided into 2 cycles (Cycle 1 and Cycle 2). Cycle 1: 10 mg or 20 mg (one or two 10 mg tablets) once daily for 4 or 5 consecutive days. Cycle 2: 10 mg or 20 mg (one or two 10 mg tablets) once daily for 4 or 5 consecutive days, starting 23 to 27 days after the last dose of Cycle 1. The second treatment course (Year 2) is given as 1.75 mg/kg, divided into 2 cycles (Cycle 3 and Cycle 4), starting approximately 12 months after the first dose of Cycle 1. Cycle 3: 10 mg or 20 mg (one or two 10 mg tablets) once daily for 4 or 5 consecutive days. Cycle 4: 10 mg or 20 mg (one or two 10 mg tablets) once daily for 4 or 5 consecutive days, starting 23 to 27 days after the last dose of Cycle 3. No further cladribine treatment is recommended in 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 is required for mild renal impairment (creatinine clearance 60-89 mL/min).
Moderate:
Not recommended for use in patients with moderate renal impairment (creatinine clearance 30-59 mL/min) due to limited clinical experience.
Severe:
Contraindicated in patients with severe renal impairment (creatinine clearance <30 mL/min).
Dialysis:
Not recommended; contraindicated in severe renal impairment.
Hepatic Impairment:
Mild:
No dose adjustment is required for mild hepatic impairment (Child-Pugh A).
Moderate:
No dose adjustment is required for moderate hepatic impairment (Child-Pugh B).
Severe:
Not recommended for use in patients with severe hepatic impairment (Child-Pugh C) due to limited clinical experience.
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. Lymphocytes, particularly T and B cells, are highly susceptible to cladribine due to their high DCK to 5'-nucleotidase ratio, which favors the accumulation of Cd-ATP. This leads to a selective, sustained reduction in lymphocyte counts, thereby reducing the autoimmune activity in MS.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 40%
Tmax:
0.5 to 1.5 hours
FoodEffect:
Food does not significantly affect the bioavailability of cladribine tablets.
Distribution:
Vd:
Approximately 98 L (intravenous)
ProteinBinding:
Approximately 20%
CnssPenetration:
Limited, but detectable levels in CSF (approximately 25% of plasma concentration)
Elimination:
HalfLife:
Approximately 24 hours (terminal half-life)
Clearance:
Approximately 22.2 L/hr (renal clearance is 8.2 L/hr)
ExcretionRoute:
Renal (primary), minor fecal
Unchanged:
Approximately 50% (renal excretion of unchanged drug)
Pharmacodynamics
OnsetOfAction:
Lymphocyte count reduction typically begins within days of the first dose.
PeakEffect:
Maximum lymphocyte reduction typically occurs within 2-3 months after the last dose of each treatment cycle.
DurationOfAction:
The therapeutic effect, including sustained lymphocyte reduction, can last for at least 2 years after the last dose of the 2-year treatment course.
Safety & Warnings
BLACK BOX WARNING
MALIGNANCY: Mavenclad may increase the risk of malignancy. Mavenclad is contraindicated in patients with active malignancies. Prior to initiating Mavenclad, patients should be screened for malignancy. Follow standard cancer screening guidelines in patients treated with Mavenclad. LYMPHOPENIA: Mavenclad causes dose-dependent reductions in lymphocyte counts. Lymphocyte counts must be assessed before and during treatment with Mavenclad. Mavenclad is contraindicated in patients with a lymphocyte count of <800 cells/mm³. If lymphopenia is severe, delay or discontinue Mavenclad.
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 or seek medical attention immediately:
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, bleeding gums, 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 Severe Symptoms: Extreme fatigue or weakness, shortness of breath, significant weight gain, or swelling in the arms or legs.
Cardiovascular Issues: Rapid or abnormal heartbeat, severe headache or dizziness, fainting, or changes in vision (indicating high blood pressure).
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.
Common Side Effects
Most people experience minimal or no side effects. However, if you encounter any of the following symptoms or any other side effects that bother you or persist, contact your doctor:
Common cold symptoms
Upset stomach
Headache
Back pain
Joint pain
Sleep disturbances
* Hair thinning or loss
Reporting Side Effects
This list is not exhaustive. If you have questions or concerns about side effects, 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 or seek medical attention immediately:
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, bleeding gums, 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 Severe Symptoms: Extreme fatigue or weakness, shortness of breath, significant weight gain, or swelling in the arms or legs.
Cardiovascular Issues: Rapid or abnormal heartbeat, severe headache or dizziness, fainting, or changes in vision (indicating high blood pressure).
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.
Common Side Effects
Most people experience minimal or no side effects. However, if you encounter any of the following symptoms or any other side effects that bother you or persist, contact your doctor:
Common cold symptoms
Upset stomach
Headache
Back pain
Joint pain
Sleep disturbances
* Hair thinning or loss
Reporting Side Effects
This list is not exhaustive. If you have questions or concerns about side effects, 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:
- Signs of infection: fever, chills, body aches, sore throat, cough, painful urination, skin rash, or sores.
- Symptoms 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.
- Signs of malignancy: new lumps or growths, unexplained weight loss, persistent cough, changes in bowel or bladder habits, unusual bleeding or bruising.
- Signs of liver problems: yellowing of the skin or eyes (jaundice), dark urine, severe stomach pain, unusual tiredness.
- Signs of hypersensitivity: rash, hives, itching, swelling of the face, lips, tongue, or throat, difficulty breathing.
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. Describe the allergic reaction and its symptoms.
Existing health conditions, such as kidney disease or liver disease.
Infections like hepatitis B, hepatitis C, HIV, or tuberculosis (TB).
Any prescription or over-the-counter medications, natural products, or vitamins you are taking, as some may interact with this medication. Specifically, certain drugs used to treat hepatitis C, HIV, infections, and other conditions should not be taken with this medication.
A diagnosis of 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, health conditions, and concerns with your doctor and pharmacist to ensure safe use. Do not initiate, stop, or modify any medication regimen without 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. Describe the allergic reaction and its symptoms.
Existing health conditions, such as kidney disease or liver disease.
Infections like hepatitis B, hepatitis C, HIV, or tuberculosis (TB).
Any prescription or over-the-counter medications, natural products, or vitamins you are taking, as some may interact with this medication. Specifically, certain drugs used to treat hepatitis C, HIV, infections, and other conditions should not be taken with this medication.
A diagnosis of 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, health conditions, and concerns with your doctor and pharmacist to ensure safe use. Do not initiate, stop, or modify any medication regimen without 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 increase the risk of infection or reduce their effectiveness when taken with this medication.
If you have taken this drug and are scheduled to receive a blood transfusion, inform your doctor, as they may need to 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 infections have been fatal. As a precautionary measure, you will be tested for hepatitis and TB before the first and second treatment courses to ensure early detection and management of these potential infections.
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 increase the risk of infection or reduce their effectiveness when taken with this medication.
If you have taken this drug and are scheduled to receive a blood transfusion, inform your doctor, as they may need to 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 infections have been fatal. As a precautionary measure, you will be tested for hepatitis and TB before the first and second treatment courses to ensure early detection and management of these potential infections.
Overdose Information
Overdose Symptoms:
- Severe lymphopenia
- Myelosuppression (anemia, neutropenia, thrombocytopenia)
- Increased risk of infection
What to Do:
There is no specific antidote for cladribine overdose. Treatment should consist of supportive medical care and close monitoring of hematologic parameters. Consider blood transfusions if necessary. Contact a poison control center immediately (e.g., Call 1-800-222-1222 in the US).
Drug Interactions
Contraindicated Interactions
- Live or attenuated vaccines (during and after treatment until lymphocyte counts recover)
- Immunosuppressants (e.g., methotrexate, cyclosporine, azathioprine, corticosteroids for chronic use) - due to additive immunosuppressive effects
- Myelosuppressive agents (e.g., carbamazepine, chloramphenicol, clozapine, interferon beta, natalizumab, mitoxantrone, teriflunomide) - due to additive myelosuppressive effects
Major Interactions
- Other disease-modifying therapies for MS (e.g., interferon beta, glatiramer acetate, natalizumab, fingolimod, teriflunomide, alemtuzumab, ocrelizumab, dimethyl fumarate) - due to potential for additive immunosuppression or myelosuppression. A washout period is generally recommended.
- Drugs that affect lymphocyte count (e.g., corticosteroids for acute use, other immunosuppressants)
Moderate Interactions
- Strong BCRP (Breast Cancer Resistance Protein) inhibitors (e.g., eltrombopag, cyclosporine, gefitinib, lapatinib, ritonavir) - may increase cladribine exposure. Use with caution.
- Strong BCRP inducers (e.g., rifampin, St. John's Wort) - may decrease cladribine exposure. Use with caution.
Minor Interactions
- Not specifically identified for minor severity interactions beyond those affecting BCRP.
Monitoring
Baseline Monitoring
Complete Blood Count (CBC) with differential
Rationale: To establish baseline lymphocyte count and identify pre-existing lymphopenia or other hematologic abnormalities. Lymphocyte count must be ≥ 800 cells/mm³ before initiating treatment.
Timing: Within 10 days prior to the first dose of each treatment course (Cycle 1 and Cycle 3).
Magnetic Resonance Imaging (MRI) of the brain
Rationale: To assess for baseline PML risk and rule out pre-existing PML.
Timing: Within 3 months prior to initiating treatment.
Tuberculosis (TB) screening
Rationale: To rule out active or latent TB infection, as cladribine can reactivate latent infections.
Timing: Prior to initiating treatment.
Hepatitis B and C serology
Rationale: To rule out active or latent viral hepatitis, as cladribine can reactivate these infections.
Timing: Prior to initiating treatment.
Varicella Zoster Virus (VZV) serology
Rationale: To determine immune status. Patients seronegative for VZV should be vaccinated prior to treatment.
Timing: Prior to initiating treatment.
Malignancy screening
Rationale: To assess for any pre-existing malignancies, as cladribine carries a risk of malignancy.
Timing: As clinically indicated, prior to initiating treatment.
Routine Monitoring
Complete Blood Count (CBC) with differential
Frequency: Before each treatment cycle (Cycle 1, 2, 3, 4) and at 2 and 6 months after the start of each treatment course (Year 1 and Year 2).
Target: Lymphocyte count ≥ 800 cells/mm³ before starting any treatment cycle. If < 500 cells/mm³ at 2 or 6 months, more frequent monitoring is needed.
Action Threshold: If lymphocyte count is < 500 cells/mm³ at the time of scheduled dosing, delay or discontinue treatment. If lymphocyte count is < 200 cells/mm³ (Grade 4 lymphopenia), monitor closely for infection and consider prophylactic antiviral/antibacterial therapy.
Signs and symptoms of infection
Frequency: Regularly throughout treatment and for at least 6 months after the last dose.
Target: Absence of fever, chills, malaise, or localized signs of infection.
Action Threshold: Prompt evaluation and management of any suspected infection. Consider delaying or discontinuing treatment if serious infection occurs.
Signs and symptoms of malignancy
Frequency: Regularly throughout treatment and for at least 4 years after the last dose.
Target: Absence of new or worsening symptoms suggestive of malignancy.
Action Threshold: Prompt evaluation of any suspected malignancy. Discontinue treatment if malignancy is diagnosed.
Symptom Monitoring
- Signs of infection (fever, chills, sore throat, cough, unusual fatigue, skin lesions)
- Symptoms of progressive multifocal leukoencephalopathy (PML) (new or worsening neurological symptoms, cognitive changes, visual disturbances)
- Symptoms of malignancy (unexplained weight loss, new lumps or growths, persistent cough, changes in bowel/bladder habits)
- Signs of hypersensitivity reactions (rash, itching, swelling, difficulty breathing)
Special Patient Groups
Pregnancy
Contraindicated in pregnant women and women of childbearing potential not using effective contraception due to potential for fetal harm (teratogenicity and embryolethality observed in animal studies).
Trimester-Specific Risks:
First Trimester:
High risk of major birth defects and embryolethality.
Second Trimester:
High risk of fetal harm, including lymphopenia and other developmental abnormalities.
Third Trimester:
High risk of fetal harm, including lymphopenia and other developmental abnormalities.
Lactation
Contraindicated during breastfeeding. Cladribine is excreted in breast milk and has the potential for serious adverse reactions in the breastfed infant.
Infant Risk:
L5 (Contraindicated - significant documented risk to infant)
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
Clinical studies did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. Use with caution in elderly patients, considering the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant disease or other drug therapy. Lymphocyte counts should be monitored closely.
Clinical Information
Clinical Pearls
- Mavenclad is a high-efficacy DMT for MS, but it requires careful patient selection and monitoring due to its safety profile, particularly regarding lymphopenia and malignancy risk.
- The treatment regimen is unique: two short courses over two years, with no further treatment typically needed for the subsequent two years, offering a 'pulsed' or 'reconstitution' therapy approach.
- Strict adherence to baseline and ongoing lymphocyte monitoring is crucial to mitigate the risk of severe lymphopenia and associated infections.
- Patients must be screened for active infections (including TB, Hepatitis B/C, VZV) and malignancies before starting treatment.
- Live or attenuated vaccines are contraindicated during and after treatment until lymphocyte counts recover. Patients should complete all necessary vaccinations prior to initiation.
- Effective contraception is mandatory for both male and female patients during treatment and for at least 6 months after the last dose due to potential genotoxicity and teratogenicity.
- Patients should be educated on the signs and symptoms of infection, PML, and malignancy, and instructed to report them immediately.
Alternative Therapies
- Fingolimod (Gilenya)
- Natalizumab (Tysabri)
- Ocrelizumab (Ocrevus)
- Alemtuzumab (Lemtrada)
- Dimethyl fumarate (Tecfidera)
- Teriflunomide (Aubagio)
- Glatiramer acetate (Copaxone)
- Interferon beta (e.g., Avonex, Betaseron, Rebif, Plegridy)
- Siponimod (Mayzent)
- Ozanimod (Zeposia)
- Ponesimod (Ponvory)
Cost & Coverage
Average Cost:
Extremely high, typically >$100,000 per year for the 2-year course per 2-year treatment course
Insurance Coverage:
Specialty Tier (requires prior authorization, step therapy, and may have high co-pays)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, 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.