Gengraf Oral

In the U.S.

• Gengraf
• Neoral
• SandIMMUNE

In Canada

• Apo-cycloSPORINE

Available Dosage Forms:

• Capsule, Liquid Filled
• Solution
• Capsule

Therapeutic Class: Immune Suppressant

Pharmacologic Class: Calcineurin Inhibitor

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Abdominal or stomach pain or tenderness
• back pain
• black, tarry stools
• blurred vision
• chest pain
• chills
• clay colored stools
• cloudy urine
• cough
• dark urine
• decrease in urine output or decrease in urine-concentrating ability
• decreased appetite
• dizziness
• drowsiness
• fever
• headache
• headache, severe and throbbing
• itching
• loss of appetite
• muscle spasms (tetany) or twitching
• nausea and vomiting
• nervousness
• painful or difficult urination
• pounding in the ears
• shakiness in the legs, arms, hands, or feet
• shortness of breath
• skin rash
• slow or fast heartbeat
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swelling of the feet or lower legs
• swollen glands
• trembling or shaking of the hands or feet
• unusual bleeding or bruising
• unusual tiredness or weakness
• yellow eyes or skin

• Bleeding gums
• blood in the urine
• blood in the vomit
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• convulsions
• difficulty swallowing
• hives
• pale skin
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• severe or continuing stomach pain
• tightness in the chest
• troubled breathing with exertion

• Bloating
• chest discomfort
• constipation
• darkened urine
• hoarseness
• indigestion
• lower back or side pain
• night sweats
• pain or discomfort in the arms, jaw, back, or neck
• pains in the stomach, side, or abdomen, possibly radiating to the back
• sweating
• vomiting of blood or material that looks like coffee grounds

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Abdominal or stomach discomfort
• bleeding, tender, or enlarged gums
• blemishes on the skin
• increased hair growth, especially on the face
• pain or tenderness around the eyes and cheekbones
• pimples
• stuffy or runny nose

• Brittle fingernails
• burning feeling in the chest or stomach
• burning, dry, or itching eyes
• continuing ringing or buzzing or other unexplained noise in the ears
• cramps
• discharge or excessive tearing
• feeling of warmth
• hearing loss
• redness of the face, neck, arms, and occasionally, upper chest
• redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
• swelling of the breasts or breast soreness in both females and males
• weight loss

• Blurred or loss of vision
• discouragement
• disturbed color perception
• double vision
• fear
• feeling sad or empty
• halos around lights
• irritability
• joint pain
• loss of interest or pleasure
• night blindness
• overbright appearance of lights
• tiredness
• trouble concentrating
• trouble sleeping
• tunnel vision
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
• weakness
• weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Cyclosporine is used to prevent organ rejection in people who have received a liver, kidney, or heart transplant. It is usually taken along with other medications to allow your new organ to function normally. Cyclosporine is also used to treat severe cases of rheumatoid arthritis and plaque psoriasis. In these conditions, the body's defense system (immune system) attacks healthy tissues. Cyclosporine belongs to a class of drugs known as immunosuppressants. It works by weakening the immune system to help your body accept the new organ as if it were your own (in the case of an organ transplant) and to prevent further damage to your joints (in the case of rheumatoid arthritis) or skin (in the case of psoriasis).

How to use Gengraf Solution

Take this medication by mouth as directed by your doctor, usually twice daily. You may take this medication with or without food, but it is important to choose one way and take this medication the same way with every dose.

The dosage is based on your weight, medical condition, lab tests, and response to treatment.

Carefully measure the dose using the medicine syringe provided. Do not use a household spoon because you may not get the correct dose. To help improve the taste, you should mix the measured dose with a glass of orange or apple juice that is at room temperature. Do not switch juices often. Do not mix this medication with milk since it may cause it to have a bad taste. Make sure to use a glass cup and not a plastic cup. Drink all of the mixture right away. Do not prepare a supply in advance. To make sure you have taken all of the medication, rinse the glass with more juice, then mix and drink. Consult your pharmacist if you have any questions.

Dry the outside of the syringe after use. Do not rinse it with water. If the syringe must be cleaned, make sure that it is completely dry before using it again.

Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.

It may take up to 4 months before you get the full benefit of this drug for the treatment of rheumatoid arthritis and psoriasis.

Tell your doctor if your condition does not get better (in 4 to 8 weeks for arthritis and in 2 to 4 weeks for psoriasis) or if it gets worse.

Before taking cyclosporine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, high blood pressure, cancer, skin lesions of unknown cause, radiation treatment (including light treatment with PUVA or UVB), mineral imbalance (such as low level of magnesium or high level of potassium), recent/current infections, high cholesterol/triglycerides levels.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

This medication may contain alcohol. Caution is advised if you are pregnant or breastfeeding or have liver disease, alcohol dependence, or any other condition that requires you to limit/avoid alcohol in your diet. Ask your doctor or pharmacist about using this product safely.

Cyclosporine can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

This medication may increase your risk of developing skin cancer. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Your doctor may direct you to avoid phototherapy while you use this product. Ask your doctor for details.

This product may increase your potassium levels. Before using potassium supplements or salt substitutes that contain potassium, consult your doctor or pharmacist.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be at greater risk for kidney problems or high blood pressure while using this drug.

During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby or cause other problems with the baby such as being born too early (premature) or having low birth weight. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Lab and/or medical tests (such as kidney/liver function, blood pressure, blood mineral levels, cyclosporine blood levels, complete blood count, uric acid levels, lipid levels, skin exam) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

If you have had an organ transplant, it is recommended that you attend a transplant education class or support group. Learn the symptoms of organ rejection such as a feeling of being ill, fever, pain around the transplanted organ, and signs of a failing transplanted organ (a decrease in the amount of urine with kidney transplant, yellowing of the skin/eyes with liver transplant, shortness of breath/inability to exercise with heart transplant). Get medical help right away if these symptoms of rejection occur.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip themissed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Storage

Store in the original bottle at room temperature. Do not refrigerate. Do not store in the bathroom. Once the bottle has been opened, use the solution within 2 months. If stored below 68 degrees F (20 degrees C), the solution may thicken and particles may form. This does not affect the medication. If this occurs, store the solution at room temperature to allow it to warm up. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.Information last revised August 2017. Copyright(c) 2017 First Databank, Inc.