cyclosporine

Generic Name: cyclosporine (SYE kloe SPOR een)
Brand Name: Gengraf, Neoral, SandIMMUNE

What is cyclosporine?

Cyclosporine lowers your body's immune system. The immune system helps your body fight infections. The immune system can also fight or "reject" a transplanted organ such as a liver or kidney. This is because the immune system treats the new organ as an invader.

Cyclosporine is used to prevent organ rejection after a kidney, heart, or liver transplant. Cyclosporine is also used to treat severe psoriasis or severe rheumatoid arthritis.

Cyclosporine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about cyclosporine?

Cyclosporine may increase your risk of developing serious infections, cancer, or transplant failure. Talk with your doctor about the risks and benefits of using this medication.

You may not be able to use this medication if you have kidney disease, untreated or uncontrolled hypertension (high blood pressure), any type of cancer, or psoriasis that has been treated with PUVA, UVB, radiation, methotrexate (Trexall), or coal tar. MAKE SURE ALL DOCTORS INVOLVED IN YOUR CARE KNOW YOU ARE TAKING CYCLOSPORINE.

Slideshow: Top Prevention Tips: Springtime Allergies

You will need regular medical tests to be sure cyclosporine is not causing harmful effects. Do not miss any follow up visits to your doctor for blood or urine tests. Avoid being near people who are sick or have infections.

Cyclosporine can harm your kidneys, and this effect is increased when you also use certain other medicines harmful to the kidneys. Many other drugs (including some over-the-counter medicines) can be harmful to the kidneys.

Cyclosporine can cause serious side effects, including kidney failure or life-threatening infection. Call your doctor at once if you have any signs of kidney failure (urinating less than usual or not at all, swelling, rapid weight gain, feeling short of breath) or signs of infection (fever, sweating, chills, tired feeling, cough, sores in your mouth and throat, flu symptoms, weight loss).

Call your doctor right away if you have symptoms of a serious brain infection, such as a change in your mental state, problems with speech or walking, or decreased vision. These symptoms may start gradually and get worse quickly.

What should I discuss with my health care provider before taking cyclosporine?

You should not use this medication if you are allergic to cyclosporine. You may not be able to use cyclosporine if you have:

• kidney disease;

• untreated or uncontrolled high blood pressure; or

• any type of cancer.

If you are being treated for psoriasis, you should not receive ultraviolet light therapy (PUVA or UVB), radiation treatments, coal tar, or drugs that weaken the immune system (such as methotrexate) while you are receiving cyclosporine.

MAKE SURE ALL DOCTORS INVOLVED IN YOUR CARE KNOW YOU ARE TAKING CYCLOSPORINE.

Cyclosporine can lower blood cells that help your body fight infections, or cause your body to produce too much of a certain type of white blood cells. This can lead to serious and sometimes fatal conditions, including cancer, a severe brain infection that can lead to disability or death, or a virus that can cause failure of a transplanted kidney. Talk with your doctor about your specific risk.

FDA pregnancy category C. It is not known whether cyclosporine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Cyclosporine can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using cyclosporine.

How should I take cyclosporine?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results.

You may take cyclosporine with or without food, but take it the same way each time. Cyclosporine should be given in two separate doses each day. Try to take the medication at the same dosing times each day.

If your doctor changes your brand, strength, or type of cyclosporine, your dosage needs may change. Ask your pharmacist if you have any questions about the new kind of cyclosporine you receive at the pharmacy.

Measure liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one. Sandimmune oral solution may be mixed with milk, chocolate milk, or orange juice at room temperature to make the medicine taste better. Neoral "modified" (microemulsion) oral solution should be mixed with orange juice or apple juice that is at room temperature.

You will need regular medical tests to be sure this medication is not causing harmful effects. Visit your doctor regularly. Do not miss any follow up visits to your doctor for blood or urine tests.

Your condition may need to be treated with a combination of different drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice. Every person taking cyclosporine should remain under the care of a doctor.

Store at room temperature away from moisture and heat.

See also: Cyclosporine dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose can cause nausea, vomiting, pain in your upper stomach, loss of appetite, jaundice (yellowing of the skin or eyes), and urinating less than usual or not at all.

What should I avoid while taking cyclosporine?

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Grapefruit and grapefruit juice may interact with cyclosporine and lead to unwanted side effects. Discuss the use of grapefruit products with your doctor.

Avoid exposure to sunlight or tanning beds. Cyclosporine can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Do not receive a "live" vaccine while using cyclosporine. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), Bacillus Calmette-Guérin (BCG), oral polio, rotavirus, smallpox, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Cyclosporine side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• fever, sweating, chills, body aches, flu symptoms, sores in your mouth and throat, weight loss;

• change in your mental state, problems with speech or walking, decreased vision (may start gradually and get worse quickly);

• easy bruising or bleeding, pale skin, confusion or weakness;

• feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

• pain in the lower back or side, blood in your urine, pain or burning when you urinate;

• urinating less than usual or not at all, rapid weight gain;

• swelling, warmth, redness, or oozing of the skin;

• vomiting and bloody diarrhea;

• seizure (convulsions);

• high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling);

• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, chest pain, shortness of breath, uneven heartbeats).

Less serious side effects may include:

• swollen or painful gums;

• mild headache;

• stomach pain, constipation, mild diarrhea; or

• tremors or shaking, muscle spasm, numbness or tingly feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: cyclosporine side effects (in more detail)

Cyclosporine Dosing Information

Usual Adult Dose for Organ Transplant -- Rejection Prophylaxis:

IV: 2 to 4 mg/kg/day IV infusion once a day over 4 to 6 hours or
1 to 2 mg/kg IV infusion twice a day over 4 to 6 hours or
2 to 4 mg/kg/day as a continuous IV infusion over 24 hours.
Capsules: 8 to 12 mg/kg/day orally in 2 divided doses.
Solution: 8 to 12 mg/kg orally once a day.
Doses are usually titrated downward with time to maintenance doses as low as 3 to 5 mg/kg/day. All doses should be adjusted to achieve the desired therapeutic concentration.

Usual Adult Dose for Rheumatoid Arthritis:

cyclosporine formulation for emulsion: 5 mg/kg/day orally divided in 2 doses. If possible, anti-inflammatory drugs should be discontinued to help avoid renal toxicity. A maximum dose of 5 mg/kg/day and a maximal increase in serum creatinine levels no more than 30% above baseline values are recommended to minimize renal toxic effects.

Cyclosporine capsules USP modified - Initial dose: 1.25 mg/kg orally twice a day.
Salicylates, nonsteroidal anti-inflammatory agents, and oral corticosteroids may be continued. Onset of action generally occurs between 4 and 8 weeks. If insufficient clinical benefit is seen and tolerability is good (including serum creatinine less than 30% above baseline), the dose may be increased by 0.5 to 0.75 mg/kg/day after 8 weeks and again after 12 weeks to a maximum of 4 mg/kg/day. If no benefit is seen by 16 weeks of therapy, cyclosporine capsules USP modified therapy should be discontinued. Dose decreases by 25% to 50% should be made at any time to control adverse events, e.g., hypertension elevations in serum creatinine (30% above the patient's pretreatment level) or clinically significant laboratory abnormalities.
If dose reduction is not effective in controlling abnormalities or if the adverse event or abnormality is severe, cyclosporine capsules USP modified should be discontinued. The same initial dose and dosage range should be used if cyclosporine capsules USP modified is combined with the recommended dose of methotrexate. Most patients can be treated with cyclosporine capsules USP modified doses of 3 mg/kg/day or below when combined with methotrexate doses of up to 15 mg/week.
There is limited long-term treatment data. Recurrence of rheumatoid arthritis disease activity is generally apparent within 4 weeks after stopping cyclosporine.

Usual Adult Dose for Ulcerative Colitis -- Active:

When refractory to corticosteroids: 4 mg/kg/day via continuous IV infusion. The dose should be titrated gradually to achieve clinical efficacy while avoiding unacceptable toxicity. Therapy should be continued for 7 to 14 days. In successful treatments, oral therapy should be instituted after 14 days of IV therapy and continued for 3 to 6 months.

Some clinicians have found a dose of 2 mg/kg/day via continuous IV infusion to be equally effective to the 4 mg/kg/day dosage regimen.

Usual Adult Dose for Psoriasis:

Refractory plaque-type psoriasis: cyclosporine formulation for emulsion: 2.5 mg/kg/day orally in 2 equally divided doses. The dose should be titrated gradually to achieve clinical efficacy while avoiding excessive toxicity. The incidence of serious toxicity increases with time thus limiting the duration of therapy. Disease relapse may occur after discontinuation or reduction in dose. A maximum dose of 5 mg/kg/day and a maximal increase in serum creatinine levels no more than 30% above baseline values are recommended to minimize renal toxic effects.

Cyclosporine capsules USP modified - Initial dose: 1.25 mg/kg twice a day.
Patients should be kept at that dose for at least 4 weeks, barring adverse events. If significant clinical improvement has not occurred in patients by that time, the patient's dosage should be increased at 2 week intervals. Based on patient response, dose increases of approximately 0.5 mg/kg/day should be made to a maximum of 4 mg/kg/day.
Dose decreases by 25% to 50% should be made at any time to control adverse events, e.g., hypertension, elevations in serum creatinine (25% above the patient's pretreatment level), or clinically significant laboratory abnormalities. If dose reduction is not effective in controlling abnormalities, or if the adverse event or abnormality is severe, cyclosporine capsules USP modified should be discontinued.
Patients generally show some improvement in the clinical manifestations of psoriasis in 2 weeks. Satisfactory control and stabilization of the disease may take 12 to 16 weeks to achieve. Treatment should be discontinued if satisfactory response cannot be achieved after 6 weeks at 4 mg/kg/day or the patient's maximum tolerated dose. Once a patient is adequately controlled and appears stable the dose of cyclosporine capsules USP modified should be lowered, and the patient treated with the lowest dose that maintains an adequate response. Doses below 2.5 mg/kg/day may also be equally effective.
Upon stopping treatment with cyclosporine, relapse will occur in approximately 6 weeks (50% of the patients) to 16 weeks (75% of the patients). In the majority of patients rebound does not occur after cessation of treatment with cyclosporine. Long-term experience with cyclosporine capsules USP modified in psoriasis patients is limited and continuous treatment for extended periods greater than one year is not recommended. Alternation with other forms of treatment should be considered in the long-term management of patients with this lifelong disease.

Usual Pediatric Dose for Organ Transplant -- Rejection Prophylaxis:

IV: 2 to 4 mg/kg/day IV infusion once a day over 4 to 6 hours or
1 to 2 mg/kg IV infusion twice a day over 4 to 6 hours or
2 to 4 mg/kg/day as a continuous IV infusion over 24 hours.
Capsules: 8 to 12 mg/kg/day orally in 2 divided doses.
Solution: 8 to 12 mg/kg orally once a day.
Doses are usually titrated downward with time to maintenance doses as low as 3 to 5 mg/kg/day. All doses should be adjusted to achieve the desired therapeutic concentration.

What other drugs will affect cyclosporine?

Cyclosporine can harm your kidneys. This effect is increased when you also use other medicines harmful to the kidneys. Many other drugs (including some over the counter medicines) can be harmful to the kidneys. You may need dose adjustments or special tests if you have recently used:

• an antibiotic or antifungal medication;

• cancer medication;

• cholesterol-lowering drugs;

• gout medication;

• medicines to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders;

• an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others;

• other medicines used to prevent organ transplant rejection; or

• stomach acid reducers (Tagamet, Zantac).

Many other drugs can interact with cyclosporine. Below is just a partial list. Tell your doctor about all other medications you are using, especially:

• birth control pills;

• a diuretic (water pill);

• gout medication;

• heart or blood pressure medication;

• HIV or AIDS medication;

• seizure medication;

• steroid medication (oral, nasal, inhaled, or injectable); or

• St. John's wort.

This list is not complete and there are many other drugs that can interact with cyclosporine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

Where can I get more information?

• Your pharmacist can provide more information about cyclosporine.