Generic Name: cyclosporine (SYE-kloe-SPOR-in)
Brand Name: Examples include Gengraf and Neoral
Gengraf suppresses the immune system, which may increase your risk of developing an infection or cancer. In kidney, liver, or heart transplant patients, Gengraf may be used along with other medicines that suppress the immune system. Using these medicines together may further increase your risk of developing an infection or cancer (eg, lymphoma).
Gengraf cannot be switched with other forms of cyclosporine (eg, Sandimmune) without your doctor's approval. If you are taking Gengraf for a transplant or for rheumatoid arthritis, lab tests may be performed to monitor your progress or to check for side effects, such as toxicity.
If you are using Gengraf for psoriasis and you have previously used certain other forms of treatment (eg, psoralen ultraviolet A [PUVA] or ultraviolet B [UVB] therapy, medicines that suppress the immune system, coal tar, radiation therapy), you may have an increased risk of developing skin cancer.
Gengraf may cause high blood pressure or kidney problems. This risk may be increased with high doses or long-term use of Gengraf. Kidney function tests must be performed while you are taking Gengraf to check for side effects.
Gengraf is used for:
Preventing the rejection of organ transplants (kidney, liver, and heart). Gengraf is also used to treat psoriasis and rheumatoid arthritis in certain patients. It may also be used for other conditions as determined by your doctor.
Gengraf is an immunosuppressant. It works by suppressing the immune system. This prevents the body from rejecting transplanted organs. This also decreases reactions in the body that cause conditions such as psoriasis and rheumatoid arthritis.
Do NOT use Gengraf if:
- you are allergic to any ingredient in Gengraf
- you have psoriasis or rheumatoid arthritis and also have kidney problems, uncontrolled high blood pressure, or cancer
- you are using other therapies for psoriasis (eg, PUVA or UVB therapy, methotrexate or other medicines that suppress the immune system, coal tar, radiation therapy)
- you have had a liver transplant and you are taking sirolimus
- you are taking aliskiren, bosentan, disulfiram, dronedarone, enzalutamide, lovastatin, metronidazole, mifepristone, orlistat, pitavastatin, a potassium-sparing diuretic (eg, spironolactone), or simvastatin
- you have taken or will be taking tacrolimus within 24 hours before or after using Gengraf
Contact your doctor or health care provider right away if any of these apply to you.
Before using Gengraf:
Some medical conditions may interact with Gengraf. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have liver, kidney, brain, or nerve problems; gout or high blood uric acid levels; low blood magnesium or cholesterol levels; high blood pressure; cancer; an infection; a weakened immune system; or problems absorbing food or medicine
- if you have high blood potassium levels or your diet contains a lot of potassium
- if you drink alcohol or have a history of alcohol abuse or seizures
- if you are having phototherapy for psoriasis or are having radiation treatment
- if you have recently had or will be having a vaccine
- if you are taking medicines that may harm the kidney (eg, aminoglycoside antibiotics [eg, gentamicin], amphotericin B, nonsteroidal anti-inflammatory drugs [NSAIDs] [eg, ibuprofen], tacrolimus, vancomycin) or the liver (eg, acetaminophen, certain medicines for HIV infection, isoniazid, ketoconazole, methotrexate). Ask your doctor if you are unsure if any of your medicines might harm the kidney or liver
Some MEDICINES MAY INTERACT with Gengraf. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Many prescription and nonprescription medicines (eg, used for aches and pains; allergic reactions; arthritis; asthma; birth control; blood thinning; cancer; diabetes; endometriosis; fibrocystic breast disease; gout; heartburn or reflux; hepatitis C; high blood pressure; high blood prolactin levels; HIV; infections; immune system suppression; inflammation; high cholesterol; irregular heartbeat or other heart problems; mental or mood problems; Parkinson disease; psoriasis; pulmonary arterial hypertension [PAH]; sleep, stomach or bowel problems; seizures; weight loss), multivitamin products, and herbal or dietary supplements (eg, St. John's wort) because they may interact with Gengraf. Ask your doctor or pharmacist if you are unsure if any of your medicines might interact with Gengraf
This may not be a complete list of all interactions that may occur. Ask your health care provider if Gengraf may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Gengraf:
Use Gengraf as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Take Gengraf by mouth with or without food. It is important to take it the same way with regard to meals. If you take it with food, try to always take it with food. If you prefer to take it on an empty stomach, then always try to take it on an empty stomach.
- Do not eat grapefruit or drink grapefruit juice while you use Gengraf.
- If you also take sirolimus, do not take it within 4 hours after taking Gengraf. Check with your doctor if you have questions.
- Take Gengraf at the same time(s) each day.
- Continue to take Gengraf even if you feel well. Do not miss any doses.
- If you miss a dose of Gengraf, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Gengraf.
Important safety information:
- Gengraf may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Gengraf with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do not switch to another doseform or change brands of Gengraf without talking to your doctor. Products made by other companies may not work as well for you.
- Gengraf may increase your risk of skin cancer. Avoid the sun, sunlamps, or tanning booths until you know how you react to Gengraf. Use a sunscreen or wear protective clothing if you must be outside for more than a short time. It may also increase your risk of developing other forms of cancer (eg, lymphoma). Discuss any questions or concerns with your doctor.
- Gengraf may lower the ability of your body to fight infection. This may increase the risk of serious and sometimes fatal infections. Avoid contact with people who have colds or infections. Tell your doctor right away if you notice signs of infection such as fever, sore throat, rash, or chills.
- Some patients treated with Gengraf have developed severe and sometimes fatal infections, such as progressive multifocal leukoencephalopathy (PML) or severe kidney problems associated with BK virus infection. In kidney transplant patients, BK virus infection may cause loss of the transplanted kidney. Tell your doctor right away if you notice symptoms of PML (eg, confusion or disorientation; you do not care about things that you usually care about; changes in thinking, strength, or vision; one-sided weakness; trouble walking or talking; loss of balance or coordination) or kidney problems (eg, change in the amount of urine produced, difficult or painful urination, blood in the urine).
- Gengraf may cause certain brain or nervous system problems, such as posterior reversible encephalopathy syndrome (PRES). Most of the time, this has gone back to normal after Gengraf was stopped. Call your doctor right away if you experience fainting, seizures, vision problems (eg, blindness), trouble walking or moving, or mental or mood changes.
- Do not receive a live vaccine (eg, measles, mumps) while you are taking Gengraf. Talk with your doctor before you receive any vaccine.
- Gengraf may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
- Check with your doctor before you use a salt substitute or a product that has potassium in it.
- Tell your doctor or dentist that you take Gengraf before you receive any medical or dental care, emergency care, or surgery.
- Patients who are being treated for psoriasis will need to have careful skin and physical examinations, including blood pressure measurements, before starting this medication.
- Diabetes patients - Gengraf may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Lab tests, including kidney and liver function, cyclosporine levels, blood pressure, lipids, and electrolytes, may be performed while you use Gengraf. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Gengraf with caution in the ELDERLY; they may be more sensitive to its effects.
- PREGNANCY and BREAST-FEEDING: Gengraf may cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Gengraf while you are pregnant. Gengraf has alcohol in it. Discuss any questions or concerns with your doctor. Gengraf is found in breast milk. Do not breast-feed while taking Gengraf.
Possible side effects of Gengraf:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Acne; dizziness; flushing; headache; increased hair growth; mild cough; mild diarrhea; nausea; runny nose; sleeplessness; stomach discomfort; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; burning, numbness, or tingling; change in the appearance of a mole; chest, jaw, or arm pain; confusion; decreased coordination; fast or irregular heartbeat; gum disease or overgrowth; mental or mood changes (eg, depression); mouth sores or swelling; muscle aches, cramps, pain, or weakness; ringing in the ears or hearing loss; seizures; severe or persistent diarrhea; severe or persistent headache or dizziness; shortness of breath; stomach pain; sudden unusual sweating; symptoms of infection (eg, chills, fever, increased or painful urination, sore throat, severe or persistent cough, warm or painful skin); symptoms of kidney problems (eg, change in the amount of urine produced, difficult or painful urination, blood in the urine); symptoms of liver problems (eg, dark urine; pale stools; severe or persistent nausea, vomiting, or loss of appetite); tremor; unusual bleeding or bruising; unusual lumps; unusual swelling; unusual thickening or growth on the skin; unusual tiredness or weakness; vision changes (eg, blindness); vomit that looks like coffee grounds; wheezing; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include drowsiness; fast or irregular heartbeat; headache; symptoms of kidney problems (eg, change in the amount of urine produced); vomiting.Proper storage of Gengraf:
Store Gengraf at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in the original container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Gengraf out of the reach of children and away from pets.
- If you have any questions about Gengraf, please talk with your doctor, pharmacist, or other health care provider.
- Gengraf is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Gengraf or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Gengraf. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Gengraf. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Gengraf.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.