Precautions

Drug information provided by: IBM Micromedex

It is very important that your doctor check your or your child's progress at regular visits to make sure that this medicine is working properly. Blood and urine tests and tests for heart function may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. You should not become pregnant during treatment with this medicine and for 2 months after the last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may cause your or your child's heart rate to slow down, especially after taking the first dose. You or your child will be observed in a hospital or clinic for 6 hours for signs and symptoms of bradycardia (slow heartbeat). Symptoms may include chest pain or discomfort, lightheadedness, dizziness, or fainting, slow or irregular heartbeat, or unusual tiredness.

Fingolimod can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection (including a serious brain infection called progressive multifocal leukoencephalopathy), which could be life-threatening. Reported infections also include bronchitis, pneumonia, varicella zoster, or herpes simplex. This risk could last up to 2 months after you stop fingolimod treatment. If you can, avoid people with infections. Check with your doctor right away if you think you or your child have an infection or if you have a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

While you are being treated with fingolimod, and for 2 months after you stop treatment with it, do not have any immunizations (vaccines) without your doctor's approval. Your child should also have a complete immunization record before starting treatment with this medicine. Fingolimod may lower your or your child's body's resistance and the vaccine may not work as well or you might get the infection the vaccine is meant to prevent. In addition, you or your child should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.

This medicine may cause macular edema (swelling of the back of the eye), especially during the first 3 to 4 months of treatment. Check with your doctor right away if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want an eye doctor (ophthalmologist) to check your eyes.

This medicine may cause a rare condition called posterior reversible encephalopathy syndrome (PRES). Check with your doctor right away if you or your child have a sudden and severe headache, confusion, vision changes, or seizures with this medicine.

Check with your doctor right away if you or your child have difficult or labored breathing or tightness in the chest while using this medicine.

Check with your doctor right away if you or your child have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause a severe increase in disability, including worsening of MS symptoms (eg, blurred vision, difficulty controlling your bladder or bowels, trouble walking, swallowing, or speaking, numbness or tingling in your arms, legs, or face, muscle spasms) for at least 12 to 24 weeks after stopping the medicine. Talk to your doctor if you have concerns about this.

This medicine may increase your risk of having skin cancer (eg, basal cell carcinoma, melanoma) or lymphoma. Tell your doctor right away if you notice any skin nodules, patches, or open sores that do not quickly heal. Avoid exposure to sunlight. Wear sunscreen with a high sun protection factor. Do not use sunlamps or tanning beds.

This medicine may cause serious allergic reactions, including angioedema, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you or your child have a rash, hives or itching skin, or large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.