Pharmacologic category

Antimetabolite (purine analog); immunosuppressant

 

Product introduction

Dosage form: 10 mg tablets

 

What is Mavenic^® used for?

Treatment of adults with relapsing forms of MS, including:

• Relapsing-remitting MS (RRMS)
• Active secondary progressive MS (active SPMS)

 

Important considerations before taking Mavenic^®

Inform your doctor or pharmacist if any of the following apply:

• Allergy to this drug, its components, or any other medications, foods, or substances
• If you are pregnant, planning to become pregnant, or breastfeeding
• If your vaccinations are not up to date, consult your doctor before starting treatment; some vaccines may be required beforehand
• Consult your doctor before receiving any vaccines, as some vaccines may increase infection risk or reduce vaccine effectiveness when used with this drug
• Inform your doctor and pharmacist about all medications you take (prescription, over-the-counter, herbal products, vitamins) and any underlying medical conditions

 

Important considerations during treatment with Mavenic^®

• Do not start, stop, or change the dose of any concomitant medication without consulting your doctor
• This drug may increase your risk of infections—wash your hands frequently and avoid people with infections, colds, or flu
• Perform blood tests and laboratory monitoring regularly as directed by your doctor
• Mavenic^® tablets are not coated and should be swallowed immediately after removal from the packaging
• If a tablet comes into contact with a surface or breaks, wash the surface thoroughly with water immediately
• Handle tablets with dry hands; wash hands thoroughly after use and avoid prolonged skin contact. Do not touch eyes, nose, or other body parts with contaminated hands
• Take the medication exactly as prescribed. If unsure, consult your doctor or pharmacist
• Tablets should be swallowed whole with water; do not chew or dissolve in the mouth
• Mavenic^® tablet can be taken with or without food
• The total prescribed dose is determined by the physician based on body weight and is administered orally in two separate treatment courses. Each course is further divided into two treatment cycles.
• The overall treatment duration is approximately two years. Each year consists of one treatment course, which includes two treatment weeks separated by about one month. Each treatment week includes 4–5 days, during which 1 or 2 tablets are taken daily.
• During the 4–5 day treatment periods with Mavenic^®, maintain at least a 3-hour interval between this medication and any other oral drug.
• Before starting each course, the physician will request blood tests to ensure adequate white blood cell (lymphocyte) levels. If lymphocyte levels are low, initiation of treatment will be delayed.

 

Use during pregnancy and breastfeeding

Pregnancy:

• Do not use Mavenic^® if you are pregnant or planning pregnancy—it may cause serious harm to the fetus
• Both men and women must use effective contraception during treatment and for 6 months (women) / 14 weeks (men) after the last dose.
• If pregnancy occurs more than 6 months after the last dose (in year one), no fetal risk is expected, but treatment cannot continue during pregnancy

Breastfeeding:

• Do not use Mavenic^® while breastfeeding
• If treatment is necessary, breastfeeding must be discontinued during treatment and for 10 days after the last dose

 

What to do if you miss a dose?

• Do not take a double or extra dose
• If you remember the missed dose on the same day, take it as soon as possible
• If you remember the next day, take the missed dose then and extend the treatment week by one day

 

Side effects

Like all medications, Mavenic^® may cause side effects, although not everyone experiences them. Contact your doctor immediately if any of the following occur:

• Signs of allergic reaction: rash, itching, hoarseness, difficulty breathing or swallowing, swelling of hands, face, or mouth
• Severe decrease in lymphocytes or other blood cells
• Signs of liver problems: nausea, vomiting, abdominal pain, fatigue, loss of appetite, yellowing of skin/eyes (jaundice), dark urine

Very common side effects (more than 1 in 10 people):

• Decreased white blood cells, red blood cells, and platelets
• Allergic reactions such as hives, itching, swelling of lips, tongue, or face
• Infections (including upper respiratory infections)
• Headache

 

Contraindications

Do not use this medication if any of the following apply:

• Allergy to cladribine or any of its components
• Active chronic infections such as HIV, tuberculosis, or hepatitis
• Weakened immune system due to disease or immunosuppressive medications
• Active cancer
• Moderate to severe kidney impairment
• Pregnancy or breastfeeding

If unsure about any of the above, consult your doctor or pharmacist before starting Mavenic®.

 

Storage instructions

• Store below 30°C, away from light and moisture, in the original packaging
• Do not use after the expiration date on the box
• Keep out of reach and sight of children
• Do not dispose of unused or expired tablets in household waste. Consult your pharmacist for proper disposal methods