Fingomod Cap

FINGOMOD CAP by SUN PHARMA LABORATORIES LTD.

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• Name:

  • Common Name: FINGOMOD CAP
  • Brand Names: Gilenya (common international brand), Tascenso ODT
  • Active Ingredient: Fingolimod

• Composition:

  • FINGOMOD CAP contains Fingolimod as its active ingredient. It is available in capsule form, typically in strengths of 0.25 mg and 0.5 mg.

• Uses:

  • FINGOMOD CAP is primarily prescribed for the treatment of relapsing forms of multiple sclerosis (MS) in adults and children 10 years of age and older. This includes clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. It works by reducing immune cells that can cause nerve damage. Some sources also mention its immunomodulating activity might help treat hospitalized cases of COVID-19.

• Dosage and Administration:

  • The recommended dosage for adults and pediatric patients (10 years and older) weighing more than 40 kg is 0.5 mg orally once daily.
  • For pediatric patients (10 years and older) weighing 40 kg or less, the recommended dosage is 0.25 mg orally once daily.
  • It can be taken with or without food, preferably at the same time each day.
  • First-dose monitoring in a medical facility for at least 6 hours is required due to potential transient heart rate slowing.

• Side Effects:

  • Common Side Effects: Headache, back pain, diarrhea, cough, flu-like symptoms, stuffy nose, sinus pain, and elevated liver transaminase levels.
  • Serious Side Effects: Slow heart rate (especially after the first dose), increased risk of serious infections (including herpes infections and PML), macular edema (swelling in the eye), Posterior Reversible Encephalopathy Syndrome (PRES), skin cancer (melanoma, basal cell carcinoma), and liver injury.

• Precautions:

  • Cardiac Evaluation: A cardiac evaluation is needed before starting treatment, especially for patients with pre-existing heart conditions or those taking medications that slow heart rate.
  • Infections: Increases the risk of serious infections. Patients should avoid live attenuated vaccines during and for 2 months after treatment.
  • Pregnancy: FINGOMOD is not recommended during pregnancy and for 2 months after stopping treatment due to potential harm to the unborn baby; effective contraception is advised.
  • Drug Interactions: Should not be taken with certain medications that prolong the QT interval or slow heart rate (e.g., amiodarone, disopyramide, sotalol).
  • Monitoring: Regular monitoring of heart function, blood counts, liver function, and eye exams is essential.

• Storage:

  • Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep out of reach of children.

FINGOMOD CAP by SUN PHARMA LABORATORIES LTD.: Frequently Asked Questions

What is Fingomod Cap used for?

Fingomod Cap (Fingolimod) is an immunomodulating medication primarily used to treat relapsing-remitting multiple sclerosis (MS) in adults and children aged 10 years and older. It is also prescribed for MS that rapidly evolves to a severe form. Some sources also indicate its use in hospitalized cases of COVID-19 to help reduce the overactive immune response seen in severe forms of the disease.

How does Fingomod Cap work?

Fingomod Cap contains fingolimod, a sphingosine 1-phosphate (S1P) receptor modulator. In MS, it works by reducing the number of lymphocytes (immune cells) in the body, primarily by trapping them in the lymph nodes. This prevents these immune cells from entering the brain and spinal cord, where they would otherwise attack the central nervous system and cause nerve damage. Its immunomodulation activity may also help reduce lung inflammation in severe COVID-19 cases.

What is the usual dosage for Fingomod Cap?

For adults and pediatric patients (10 years and older) weighing more than 40 kg, the recommended dosage is 0.5 mg orally once daily. For pediatric patients (10 years and older) weighing 40 kg or less, the recommended dosage is 0.25 mg orally once daily. It can be taken with or without food, but should be taken at the same time each day for maximum benefit. Capsules should be swallowed whole and not crushed or chewed.

What are the possible side effects of Fingomod Cap?

Common side effects include flu-like symptoms, headache, diarrhea, back pain, and cough. More serious side effects can include an increased risk of infections, a slowed heartbeat (especially after the first dose), changes in vision, liver injury, and certain types of skin cancer (such as melanoma or basal cell carcinoma). You should report any persistent or concerning side effects to your doctor.

Is Fingomod Cap safe during pregnancy or breastfeeding?

Fingomod Cap is generally not recommended during pregnancy or for women planning to become pregnant, as it may cause harm to the unborn baby, including birth defects. Women of childbearing potential should use effective contraception during treatment and for two months after stopping the medication. For breastfeeding, it is generally advised to avoid Fingomod Cap due to potential toxicity to the infant and the lack of comprehensive data on its effects in breastfed infants, though one source states it is "probably safe if prescribed."

Can Fingomod Cap be taken with other medications?

Fingomod Cap can interact with several medications. It should not be taken with live virus vaccines. Combining it with other immunosuppressants or immunomodulators can increase the risk of severe immunosuppression. Medications that slow heart rate or atrioventricular conduction, such as beta-blockers, digoxin, diltiazem, verapamil, amiodarone, quinidine, disopyramide, dofetilide, dronedarone, ibutilide, procainamide, and sotalol, can cause severe bradycardia (slow heart rate) when taken concurrently with Fingomod Cap. Always inform your doctor about all medications, supplements, and herbal products you are taking.

What precautions should be taken while taking Fingomod Cap?

Before starting Fingomod Cap, your doctor will likely perform a baseline electrocardiogram (ECG) and blood pressure measurement. You will be monitored for at least 6 hours after your first dose (or after a dose increase/restart) for signs of a slowed heartbeat. Regular blood tests to monitor white blood cell count and liver function are also recommended during treatment. You should protect your skin from excessive sun exposure by wearing protective clothing and sunscreen, as Fingomod Cap can increase sensitivity to sunlight and the risk of skin cancer. Inform your doctor about any pre-existing heart conditions, severe liver or kidney disease, lung problems, diabetes, or vision issues. Do not stop taking the medicine suddenly without consulting your doctor, as this can worsen your condition.

What happens if a dose of Fingomod Cap is missed?

If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take your next dose at the regularly scheduled time. Do not take a double dose to make up for a missed one. If you miss several doses, especially within the first few weeks of treatment, contact your doctor, as you may need to undergo first-dose monitoring again.

How should Fingomod Cap be stored?

Fingomod Cap should be stored at room temperature, away from excessive heat, moisture, and direct light. Do not store it above 25°C. Keep the medication in its closed container and out of the sight and reach of children.