ACH-Fingolimod

The usual adult dose is 0.5 mg once a day, taken by mouth with half a glass of water. Fingolimod can be taken with or without food.

Children (over 10 years old) who weigh 40 kg and less should take 0.25 mg once daily. Children who weigh more than 40 kg should take 0.5 mg once daily.

Fingolimod will stay in your body for up to 2 months after you stop taking it. Your white blood cell count (lymphocyte count) may also remain low during this time and you may still experience side effects.

You will take the first dose of fingolimod in your doctor's office or clinic and will need to stay at the office for at least 6 hours after the first dose. You may also need to stay if your dose is increased from 0.25 to 0.5 mg daily. This will allow the doctor to monitor for side effects such as slowed heartbeat and treat any problems before they become an emergency.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important that this medication be taken exactly as prescribed by your doctor. If you miss a dose, take the next dose as planned. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

If you have been taking this medication for **less than 2 weeks **and you forget to take a dose for one day or more, or if you stop taking fingolimod for more than 7 days after 3 or 4 weeks of treatment, contact your doctor as soon as possible. Your doctor may choose to monitor you for heart and blood pressure effects before you restart the medication.

If this medication is stopped for more than 2 weeks, contact your doctor. You will need to be monitored for heart and blood pressure effects again when you restart the medication.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g., down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Each bright yellow opaque / white opaque size "3" hard gelatin capsule, filled with white-to-off-white powder, imprinted with "FO 0.5 mg" on the cap and two radial bands on the capsule body with yellow ink, contains 0.5 mg of fingolimod. Nonmedicinal ingredients: pregelatinized starch, magnesium stearate; capsule shell: gelatin, titanium dioxide, yellow iron oxide; black ink: propylene glycol, potassium hydroxide, black iron oxide; yellow ink: propylene glycol, yellow iron oxide.

Do not take fingolimod if you:

• are allergic to fingolimod or any ingredients of the medication

• have a severe active infection or an active chronic infection such as hepatitis or tuberculosis

• have a weakened immune system due to disease (e.g., immunodeficiency syndrome) or use medicines or treatments that suppress the immune system (e.g., to treat cancer or bone marrow transplantation)

• have an active cancer (except for a type of skin cancer called basal cell carcinoma)

• have severe liver disease

• have had a heart attack, unstable angina, a transient ischemic attack (mini-stroke), or heart failure in the past 6 months

• have a severe irregular heartbeat and are taking certain medications to treat it

• have heart block or sick-sinus syndrome and do not have a pacemaker

• have a prolonged QT interval

• are or may become pregnant and are not using effective birth control

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• back pain

• breathlessness

• cough

• diarrhea

• dizziness

• eye pain

• flu virus infection with symptoms such as tiredness, chills, sore throat, joint or muscle aches, or fever

• hair loss

• headache

• itchy skin

• joint or muscle pain

• migraine

• nausea

• sinus infection

• skin rash

• tingling or sensation of numbness

• weakness

• weight loss

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• blurred vision

• disease flare-ups after stopping medication

• fungal infections affecting hair, nails, or skin

• HPV infection (e.g., genital warts, abnormal growth, HPV-related cancer)

• increased blood pressure

• signs of anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)

• signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don't stop bleeding)

• signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)

• signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)

• signs of liver problems (e.g., nausea, vomiting, loss of appetite, swelling and/or pain in the abdomen, fatigue, itching, yellowing of the skin or eyes, or dark urine)

• symptoms of bronchitis such as cough with phlegm, chest pain, or fever

• symptoms of infection from herpes virus (shingles or herpes zoster) such as blisters, burning, itching, or pain around the mouth or genitals (other symptoms may include fever followed by numbness, itching, and red patches or blisters on the face or trunk, with severe pain)

• symptoms of gastroenteritis such as vomiting, nausea, diarrhea, or fever

• symptoms of irregular heartbeat (e.g., chest pain; dizziness; rapid, pounding heartbeat; shortness of breath)

• symptoms of lymphoma (e.g., swelling lymph nodes, swollen tonsils, fever, chills, night sweats, fatigue, itching, unexplained weight loss, loss of appetite, difficulty breathing)

• symptoms of macular edema (swelling in the central vision area of the retina at the back of the eye) such as shadows or blind spots in the centre of your vision, blurred vision, or problems seeing colours or details

• symptoms of pneumonia such as fever, cough, or difficulty breathing

• symptoms of slow heartbeat (e.g., dizziness, fatigue, decreased blood pressure)

• trouble breathing

• unusual growths on the skin (e.g., shiny, raised growths or purple, red, or brown blotches)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• encephalopathy (symptoms include confusion, drowsiness, personality change, headache, paralysis, abnormal speech, or convulsions)

• irregular heartbeat

• peripheral artery disease (symptoms include cold, painful, or discoloured fingers, toes, or limbs)

• seizures

• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)

• symptoms of stroke (e.g., weakness and/or loss of sensation of limbs or face, difficulty speaking, headache, dizziness, clumsiness, or vision problems)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

HEALTH CANADA ADVISORY

January 18, 2021

Health Canada has issued new information concerning the use of fingolimod. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.

Previous advisories on fingolimod were issued on December 19, 2019.

Anemia: Fingolimod ****may cause a decreased production of red blood cells by the body. If you experience symptoms of reduced red blood cell count (anemia) such as shortness of breath, feeling unusually tired, or pale skin, contact your doctor as soon as possible.

Bleeding: Fingolimod may cause a reduced number of platelets in the blood, which can make it difficult to stop cuts from bleeding. If you notice any signs of bleeding, such as frequent nosebleeds, unexplained bruising, or black and tarry stools, notify your doctor as soon as possible. Your doctor will order routine blood tests to make sure potential problems are caught early.

**Blood pressure: **Fingolimod may also increase blood pressure and is not recommended for people who have uncontrolled high blood pressure. If you have high blood pressure, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Breathing disorders: Fingolimod may affect lung function for people with respiratory problems such as pulmonary fibrosis, asthma, and chronic obstructive pulmonary disease. If you have respiratory problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Contact your doctor if you experience any new or worsening shortness of breath.

If you have sleep apnea (periods during sleep when you stop breathing), talk to your doctor before starting fingolimod. Very low heart rate may cause episodes of sleep apnea to become worse.

Cancer: Fingolimod reduces the number of cells that fight infection in the body (white blood cells). This may increase your risk of developing infections and certain types of skin cancer and lymphoma (cancer of the lymph nodes).

While you are taking fingolimod, it is important to limit your exposure to the sun and use appropriate sun protection such as sunscreen and protective clothing. Your doctor will monitor you for skin cancer while you are taking this medication. Talk to your doctor if you have any concerns.

Cholesterol: Treatment with fingolimod may result in increased levels of total cholesterol, LDL cholesterol, and triglycerides. If you have or are at increased risk of having high cholesterol, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Depression: People with MS often experience depression more often than the general public. Fingolimod may contribute to the symptoms of depression. If you have depression or a history of depression, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you experience symptoms of depression such as poor concentration, changes in weight, changes in sleep, decreased interest in activities, or notice them in a family member who is taking this medication, contact your doctor as soon as possible.

**Eye problems: **People who have diabetes or a history of inflammation of the middle of the eye are at an increased risk of developing swelling in the macula of the eye. It is recommended that you have an eye examination after taking this medication for 3 or 4 months to check for changes in your eyes that have not caused symptoms. Report any changes in vision to your doctor as soon as possible.

Heart problems: Fingolimod causes a decrease in heart rate a few hours after taking the first dose. Your doctor will want to check your heart before you start this medication. You will also need to be observed in a doctor's office or clinic for 6 hours after your first dose. This allows the doctor to monitor your heart rate and treat any problems before they become an emergency. It may be necessary to be monitored for a longer period of time if you develop very low heart rate or an arrhythmia. People with certain heart conditions such as heart arrhythmias, angina, congestive heart failure or a history of heart attack, should not take fingolimod. Fingolimod may also cause mild increases in blood pressure.

If you have a heart problem, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Heart rhythm: This medication can cause changes to the normal rhythm of the heart, including an irregular heartbeat called QT prolongation. QT prolongation is a serious life-threatening condition that can cause fainting, seizures, and sudden death. If you are at risk for heart rhythm problems (e.g., people with heart failure, angina, low potassium or magnesium levels), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Infections: Fingolimod works by decreasing the number of white blood cells in the blood stream. White blood cells are responsible for fighting infection in the body. As a result, people taking fingolimod may have an increased risk of infections. If you notice signs of an infection, such as fever, redness, or swelling, contact your doctor as soon as possible. Rarely, people taking fingolimod have experienced life threatening infections caused by varicella zoster (chicken pox, shingles) and herpes simplex viruses.

Kidney function: Kidney disease or reduced kidney function may cause this medication to build up in the body, causing side effects. If you have reduced kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

**Liver function: **Liver disease or reduced liver function may cause fingolimod to build up in the body, causing side effects. This medication may also reduce liver function and can cause liver failure. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Progressive multifocal leukoencephalopathy (PML): There have been reports of PML after using fingolimod. PML is a rare viral infection that causes nerve damage in the brain. If you experience memory loss, vision changes, trouble thinking, personality changes or difficulty walking, contact your doctor immediately.

**Posterior Reversible Encephalopathy Syndrome (PRES): **This is a rare disease of the brain that may occur when using fingolimod. If you have had a previous episode of PRES, this may not be an appropriate medication for you. Make sure your doctor knows you have experienced this before. If you experience signs and symptoms of PRES, such as headache, nausea, vomiting, seizures, change in awareness or consciousness, or vision changes, contact your doctor immediately.

**Seizures: **If you have a history of seizures, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Fingolimod may increase the frequency of seizures.

Stopping this medication: This medication takes approximately 2 months to completely leave the body once you stop taking it. During this time, side effects and interactions with other medications may continue.

Once fingolimod has been stopped, symptoms of MS return and may potentially worsen.

Vaccines: If you have not had chickenpox or been vaccinated against chickenpox, talk to your doctor about receiving the chickenpox (Varicella zoster) vaccine at least 1 month before starting fingolimod treatment. During and for up to 2 months after stopping treatment with fingolimod, some vaccines containing live viruses may result in the infection that the vaccination should prevent, while other vaccines may not work well enough to protect you. Talk to your doctor about which vaccinations you need before starting treatment, and which vaccines to avoid during treatment.

Pregnancy: This medication may cause harm to an unborn fetus and should not be used during pregnancy. If you become pregnant while taking this medication, contact your doctor immediately. If you are taking fingolimod and could become pregnant, you should use an effective method of birth control (e.g., birth control pill, condoms) during treatment, and for 2 months after stopping treatment with fingolimod.

Breast-feeding: This medication passes into breast milk. If you are breast-feeding and are taking fingolimod, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children under the age of 10 years. Children should complete routine immunizations prior to starting treatment with this medication.

Seniors: Seniors may be more at risk of side effects from this medication.

There may be an interaction between fingolimod and any of the following:

• anticancer medications (e.g., azacitidine, busulfan, capecitabine, cladribine, cytarabine, doxorubicin, etoposide, ifosfamide, mitoxantrone, vincristine)

• "azole" antifungals (e.g., itraconazole, ketoconazole, voriconazole)

• baricitinib

• BCG

• beta-adrenergic blockers (e.g., atenolol, propranolol, sotalol)

• carbamazepine

• clonidine

• corticosteroids (e.g., dexamethasone, hydrocortisone, prednisone)

• cyclosporine

• denosumab

• digoxin

• diltiazem

• donepezil

• dronedarone

• echinacea

• fentanyl

• formoterol

• galantamine

• guanfacine

• haloperidol

• ivabradine

• lacosamide

• lanreotide

• leflunomide

• macrolide antibiotics (e.g., clarithromycin, erythromycin)

• medications for irregular heartbeat such as amiodarone, disopyramide, procainamide, quinidine, or sotalol

• medications that suppress or modulate the immune system, including medications used to treat MS (e.g., beta-interferon, glatiramer acetate, natalizumab)

• methadone

• midodrine

• mycophenolate

• octreotide

• ozanimod

• pasireotide

• pimecrolimus

• quinine

• rivastigmine

• roflumilast

• romidepsin

• salmeterol

• tacrolimus

• tizanidine

• tyrosine kinase inhibitors (e.g., bosutinib, ceritinib, dasatinib, nilotinib, sunitinib, tofacitinib)

• vaccines

• verapamil

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,

• change one of the medications to another,

• change how you are taking one or both of the medications, or

• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking.

Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2024. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/ACH-Fingolimod