Cyclosporine (Oral)

Generic name: Cyclosporine
Drug class: Calcineurin inhibitors

Usage of Cyclosporine (Oral)

Cyclosporine is used in combination with other medicines (eg, azathioprine, steroid medicines) to prevent the body from rejecting a transplanted organ (eg, kidney, liver, or heart). It belongs to a group of medicines known as immunosuppressive agents. When a patient receives an organ transplant, the body's white blood cells will try to get rid of (reject) the transplanted organ. Cyclosporine works by suppressing the immune system to prevent the white blood cells from trying to get rid of the transplanted organ.

Cyclosporine is also used to treat severe active rheumatoid arthritis in patients who have taken other medicines (eg, methotrexate) that did not work well. It is also used to treat severe plaque psoriasis, which is a skin disease with red patches and white scales that do not go away. It is given to patients who have received other types of treatment (eg, PUVA, retinoids, methotrexate) that did not work well.

This medicine is available only with your doctor's prescription.

Cyclosporine (Oral) side effects

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:

More common

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

skin rash

slow or fast heartbeat

sore throat

sores, ulcers, or white spots on the lips or in the mouth

stomach pain or tenderness

swelling of the feet or lower legs

swollen glands

trembling or shaking of the hands or feet

trouble breathing

unusual bleeding or bruising

unusual tiredness or weakness

yellow eyes or skin

Less common

Bleeding gums

blood in the urine

blood in the vomit

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

chest tightness

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

seizures

severe or continuing stomach pain

Rare

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:

More common

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

stomach discomfort

stuffy or runny nose

Less common

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

Rare

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

trouble concentrating

trouble sleeping

tunnel vision

unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

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.

Before taking Cyclosporine (Oral)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies on the relationship of age to the effects of cyclosporine have not been performed in children receiving organ transplants. However, no pediatric-specific problems have been documented to date.

Appropriate studies have not been performed on the relationship of age to the effects of cyclosporine in children with rheumatoid arthritis or psoriasis. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of cyclosporine in the elderly. However, elderly patients are more likely to have high blood pressure or age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving cyclosporine.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Bosentan

Colchicine

Dronedarone

Elagolix

Eliglustat

Grazoprevir

Lercanidipine

Levoketoconazole

Mifepristone

Pitavastatin

Simvastatin

Sitaxsentan

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Abametapir

Abrocitinib

Acalabrutinib

Aceclofenac

Acemetacin

Adagrasib

Adalimumab

Afatinib

Alefacept

Alfalfa

Alfentanil

Aliskiren

Alprazolam

Amifampridine

Amlodipine

Amtolmetin Guacil

Apixaban

Aprepitant

Asciminib

Aspirin

Atogepant

Atorvastatin

Avacopan

Avapritinib

Bacillus of Calmette and Guerin Vaccine, Live

Belzutifan

Benzhydrocodone

Berotralstat

Betrixaban

Bimekizumab-bkzx

Black Cohosh

Bosutinib

Brigatinib

Bromfenac

Budesonide

Bufexamac

Buprenorphine

Bupropion

Carbamazepine

Caspofungin

Celecoxib

Ceritinib

Cerivastatin

Cholic Acid

Choline Salicylate

Clonixin

Clozapine

Cobicistat

Codeine

Conivaptan

Crizotinib

Cyclophosphamide

Dabigatran Etexilate

Dabrafenib

Daridorexant

Darunavir

Dasabuvir

Deflazacort

Dengue Tetravalent Vaccine, Live

Desogestrel

Dexibuprofen

Dexketoprofen

Diclofenac

Dienogest

Diflunisal

Dihydrocodeine

Diltiazem

Diphtheria Toxoid, Adsorbed

Dipyrone

Domperidone

Donepezil

Doxorubicin

Doxorubicin Hydrochloride Liposome

Drospirenone

Droxicam

Efavirenz

Elacestrant

Elexacaftor

Eluxadoline

Enasidenib

Encorafenib

Entrectinib

Enzalutamide

Erdafitinib

Estetrol

Estradiol

Ethinyl Estradiol

Ethynodiol

Etodolac

Etofenamate

Etoposide

Etoricoxib

Etravirine

Everolimus

Ezetimibe

Fedratinib

Felbinac

Felodipine

Fenoprofen

Fentanyl

Fepradinol

Feprazone

Fexinidazole

Finerenone

Floctafenine

Fluconazole

Flufenamic Acid

Flurbiprofen

Fosaprepitant

Foscarnet

Fosnetupitant

Gepirone

Gestodene

Glecaprevir

Haemophilus B Vaccine

Hepatitis A Vaccine, Inactivated

Hydrocodone

Hydroxychloroquine

Ibrutinib

Ibuprofen

Ibuprofen Lysine

Indomethacin

Infigratinib

Infliximab

Influenza Virus Vaccine

Isavuconazonium Sulfate

Itraconazole

Ivacaftor

Ivosidenib

Ketoprofen

Ketorolac

Lanreotide

Larotrectinib

Lasmiditan

Lefamulin

Lemborexant

Lenacapavir

Letermovir

Levamlodipine

Levonorgestrel

Lorlatinib

Lornoxicam

Lovastatin

Loxoprofen

Lumacaftor

Lumateperone

Lumiracoxib

Lurbinectedin

Lyme Disease Vaccine (Recombinant OspA)

Mavacamten

Measles Virus Vaccine, Live

Meclofenamate

Mefenamic Acid

Meloxicam

Melphalan

Meningococcal Vaccine

Meperidine

Mestranol

Methadone

Methotrexate

Metoclopramide

Mitapivat

Mitotane

Mobocertinib

Momelotinib

Morniflumate

Morphine

Morphine Sulfate Liposome

Mumps Virus Vaccine, Live

Mycophenolate Mofetil

Mycophenolic Acid

Nabumetone

Nafcillin

Naproxen

Nepafenac

Neratinib

Netupitant

Nicardipine

Nifedipine

Niflumic Acid

Nimesulide

Nimesulide Beta Cyclodextrin

Nirmatrelvir

Nomegestrol

Norethindrone

Norgestimate

Norgestrel

Obeticholic Acid

Octreotide

Olaparib

Omaveloxolone

Ombitasvir

Orlistat

Oxaprozin

Oxycodone

Oxyphenbutazone

Ozanimod

Pacritinib

Palbociclib

Palovarotene

Parecoxib

Paritaprevir

Pazopanib

Pemigatinib

Pentazocine

Perindopril

Pertussis Vaccine

Pexidartinib

Phenobarbital

Phenylbutazone

Pibrentasvir

Piketoprofen

Piperaquine

Piroxicam

Pirtobrutinib

Pixantrone

Plague Vaccine

Pneumococcal Vaccine, Diphtheria Conjugate

Pneumococcal Vaccine Polyvalent

Poliovirus Vaccine, Live

Posaconazole

Potassium Phosphate

Pralsetinib

Pravastatin

Primidone

Proglumetacin

Propionic Acid

Propyphenazone

Proquazone

Pyrazinamide

Rabies Vaccine

Ranolazine

Red Yeast Rice

Relugolix

Revefenacin

Ribociclib

Rifabutin

Rifampin

Rimegepant

Ritlecitinib

Ritonavir

Rivaroxaban

Rofecoxib

Rosuvastatin

Rotavirus Vaccine, Live

Rubella Virus Vaccine, Live

Salicylic Acid

Salsalate

Selpercatinib

Selumetinib

Silodosin

Simeprevir

Sirolimus Protein-Bound

Smallpox Vaccine

Sodium Salicylate

Sonidegib

Sotorasib

Sparsentan

St John's Wort

Sufentanil

Sulfinpyrazone

Sulindac

Tacrolimus

Taurursodiol

Tazemetostat

Telaprevir

Telithromycin

Tenofovir Alafenamide

Tenoxicam

Tepotinib

Tetanus Toxoid

Tezacaftor

Tiaprofenic Acid

Tocilizumab

Tofacitinib

Tolfenamic Acid

Tolmetin

Tolvaptan

Topotecan

Tramadol

Trofinetide

Tucatinib

Typhoid Vaccine, Live

Ubrogepant

Ustekinumab

Valdecoxib

Varicella Virus Vaccine, Live

Venetoclax

Venlafaxine

Vilazodone

Vincristine

Vincristine Sulfate Liposome

Voclosporin

Vonoprazan

Voriconazole

Voxelotor

Voxilaprevir

Yellow Fever Vaccine

Zanubrutinib

Zavegepant

Zolpidem

Zoster Vaccine, Live

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acetazolamide

Allopurinol

Ambrisentan

Amiodarone

Amphotericin B

Amphotericin B Cholesteryl Sulfate Complex

Amphotericin B Lipid Complex

Amphotericin B Liposome

Amprenavir

Azathioprine

Boceprevir

Bromocriptine

Chloramphenicol

Chloroquine

Cimetidine

Ciprofloxacin

Cisapride

Clarithromycin

Clindamycin

Clonidine

Colesevelam

Dalfopristin

Danazol

Digoxin

Dirithromycin

Erythromycin

Famotidine

Fenofibrate

Fluvoxamine

Fosamprenavir

Fosphenytoin

Furosemide

Glipizide

Glyburide

Imipenem

Indinavir

Josamycin

Ketoconazole

Mercaptopurine

Methylprednisolone

Metronidazole

Mibefradil

Midazolam

Miokamycin

Modafinil

Nefazodone

Nelfinavir

Nevirapine

Norfloxacin

Oxypurinol

Phenytoin

Probucol

Propafenone

Quinine

Quinupristin

Repaglinide

Rifapentine

Saquinavir

Semaglutide

Sirolimus

Sulfadiazine

Sulfasalazine

Suvorexant

Terbinafine

Tigecycline

Tobramycin

Tolterodine

Troglitazone

Verapamil

Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Grapefruit Juice

Pomelo Juice

Relate drugs

How to use Cyclosporine (Oral)

Take this medicine exactly as directed by your doctor. Do not take more or less of it and do not take it more often than your doctor ordered. Using too much will increase the chance for side effects, while using too little may cause you to reject your transplanted organ.

This medicine is always used together with other medicines. Make sure you understand when to take all of your medicines. Your doctor will give you a daily plan for taking your medicines.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

Take this medicine the same way every day. Take it at the same time and take it consistently, either with or without food.

Measure the oral liquid only with the dosing syringe that comes with the package. The dosing syringe should be wiped with a clean towel after it is used and stored in its container. Do not rinse the dosing syringe with water or other cleaning agents before or after use.

To make Neoral® oral liquid taste better, mix it in a glass container with apple juice or orange juice (preferably at room temperature). Use a glass container, not plastic. Stir it well and drink it immediately. After drinking all the liquid containing the medicine, rinse the glass with a little more liquid and drink that also, to make sure you get all the medicine.

To make Sandimmune® oral liquid taste better, mix it in a glass container with milk, chocolate milk, or orange juice (preferably at room temperature).

You should not eat grapefruit or drink grapefruit juice while you are using this medicine. Grapefruit and grapefruit juice will increase the amount of medicine in the body.

Do not stop taking this medicine without first checking with your doctor. You might have to take medicine for the rest of your life to prevent your body from rejecting the transplant.

If you are using sirolimus, take it 4 hours after you use cyclosporine.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage forms (capsules or oral solution):

For prevention of transplant rejection:

Adults and children—

Neoral®: Your dose will be determined by your doctor (depends on the transplanted organ). This is taken 4 to 12 hours before organ transplantation or after transplantation. Your doctor may adjust your dose as needed.

Sandimmune®: Dose is based on body weight and must be determined by your doctor. The starting dose is usually 15 mg per kg of body weight. This is taken as a single dose 4 to 12 hours before organ transplantation and continued after transplantation as directed by your doctor. Your doctor may adjust your dose as needed.

For treatment of psoriasis:

Adults—Dose is based on body weight and must be determined by your doctor. The starting dose is usually 2.5 milligrams (mg) per kilogram (kg) of body weight per day, divided into two doses. Your doctor may adjust your dose as needed.

Children—Use and dose must be determined by your doctor.

For treatment of rheumatoid arthritis:

Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Do not keep the oral liquid in the refrigerator. Throw away any unused medicine 60 days after the bottle is opened for the first time.

Warnings

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

You will also need to have your blood pressure measured before starting this medicine and while you are using it. If you notice any change to your recommended blood pressure, call your doctor right away. If you have questions about this, talk to your doctor.

Do not take cyclosporine if you are receiving treatment for psoriasis, including PUVA or UVB therapy, methotrexate (Rheumatrex®), coal tar, or radiation therapy.

Check with your doctor right away if you have blood in the urine, change in the frequency of urination or amount of urine, difficulty breathing, drowsiness, increased thirst, loss of appetite, nausea or vomiting, or swelling of the feet or lower legs, or weakness. These may be symptoms of a serious kidney problem.

Do not use supplements or salt substitutes containing potassium without first checking with your doctor.

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

This medicine may increase your risk of getting skin cancer or lymphoma. Talk to your doctor if you have concerns about this risk.

This medicine may increase your risk of developing infections. Avoid being near people who are sick while you are using this medicine. Wash your hands often. Tell your doctor if you have any kind of infection before you start using this medicine. Tell your doctor if you have ever had an infection that would not go away or an infection that kept coming back.

This medicine may cause thrombotic microangiopathy (damage in the smallest blood vessels) and hemolytic anemia. Tell your doctor right away if you have back, leg, or stomach pains, bleeding gums, chills, dark urine, difficulty breathing, fever, general body welling, headache, loss of appetite, nausea or vomiting, nosebleeds, pale skin, sore throat, sudden, severe chest pain, sudden weakness in arms or legs, or yellowing of the eyes or skin.

Tell your doctor if you are taking a corticosteroid or another medicine that may weaken your immune system. This may increase your risk for developing a serious infection.

If you are taking this medicine after a kidney transplant, it may increase your risk for developing rare and serious virus infections, including polyoma virus-associated nephropathy (PVAN), progressive multiple leukoencephalopathy (PML), and BK virus-associated nephropathy (BKVAN). The BK virus may affect how your kidneys work and cause a transplanted kidney to fail. Check with your doctor right away if you have bloody urine, a decreased frequency or amount of urine, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain.

Tell your doctor right away if you have seizures, headaches, confusion, vision problems, unusual drowsiness, tiredness, or weakness. These could be symptoms of a serious nervous system problem called posterior reversible encephalopathy syndrome (PRES).

While you are being treated with cyclosporine, and after you stop treatment with it, do not have any immunizations (vaccines) without your doctor's approval. Cyclosporine may lower your 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 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.

In some patients (usually younger patients), tenderness, swelling, or bleeding of the gums may appear soon after treatment with cyclosporine is started. Brushing and flossing your teeth, carefully and regularly, and massaging your gums may help prevent this. See your dentist regularly to have your teeth cleaned. Check with your medical doctor or dentist if you have any questions about how to take care of your teeth and gums, or if you notice any tenderness, swelling, or bleeding of your gums.

This medicine may make your skin more sensitive to sunlight and can increase your risk of having skin cancer. If you are being treated for psoriasis, check with your doctor first before having an ultraviolet (UV) light treatment. Use a sunscreen when you are outdoors and avoid sunlamps and tanning beds.

This medicine may cause a serious nervous system problem. Tell your doctor right away if you have confusion, loss of consciousness, mental changes, muscle weakness, seizures, or vision changes.

This medicine may cause dizziness, confusion, or sleepiness. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

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 (eg, St. John's wort) or vitamin supplements.

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