Pronunciation:

sye-kloe-SPOR-een

Brand Names:

• SandIMMUNE

Dosage Forms:

• Solution

Warnings:

Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe cyclosporine. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient.Cyclosporine should be administered with adrenal corticosteroids but not with other immunosuppressive agents. Increased susceptibility to infection and the possible development lymphoma may result from immunosuppression.Cyclosporine capsules and cyclosporine solution have decreased bioavailability in comparison to cyclosporine MODIFIED capsules and cyclosporine MODIFIED solution.Cyclosporine and cyclosporine MODIFIED are not bioequivalent and cannot be used interchangeably without physician supervision.The absorption of cyclosporine during chronic administration of cyclosporine capsules and oral solution was found to be erratic. It is recommended that patients taking the soft gelatin capsules or oral solution over a period of time be monitored at repeated intervals for cyclosporine blood concentrations and subsequent dose adjustments be made in order to avoid toxicity due to high concentrations and possible organ rejection due to low absorption of cyclosporine. This is of special importance in liver transplants. Numerous assays are being developed to measure blood concentrations of cyclosporine. Comparisons of concentrations in published literature to patient concentrations using current assays must be done with detailed knowledge of the assay methods employed .

Classifications:

Therapeutic—

Immune Suppressant

Pharmacologic—

Calcineurin Inhibitor

Uses of This Medicine:

Cyclosporine injection is used in combination with other medicines (eg, 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.

This medicine is to be given only by or under the direct supervision of a doctor.

Before Using This Medicine:

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.

Children—

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

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of cyclosporine injection 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 injection.

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.

Other 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 receiving 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
• Ezetimibe
• 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
• Adenovirus Vaccine, Live
• Afatinib
• Alefacept
• Alfalfa
• Alfentanil
• Aliskiren
• Alogliptin
• Alpelisib
• Alprazolam
• Ambrisentan
• Amifampridine
• Amiloride
• Amlodipine
• Amphotericin B
• Amprenavir
• Amtolmetin Guacil
• Apalutamide
• Apazone
• Apixaban
• Aprepitant
• Asciminib
• Aspirin
• Asunaprevir
• Atogepant
• Atorvastatin
• Avacopan
• Avapritinib
• Azilsartan
• Azilsartan Medoxomil
• Azithromycin
• Bacillus of Calmette and Guerin Vaccine, Live
• Belzutifan
• Benazepril
• Benzhydrocodone
• Berotralstat
• Betrixaban
• Bezafibrate
• Bimekizumab-bkzx
• Black Cohosh
• Boceprevir
• Bosutinib
• Brigatinib
• Bromfenac
• Bromocriptine
• Budesonide
• Bufexamac
• Buprenorphine
• Bupropion
• Canagliflozin
• Candesartan
• Canrenoate
• Canrenone
• Capivasertib
• Capmatinib
• Captopril
• Carbamazepine
• Caspofungin
• Celecoxib
• Cenobamate
• Ceritinib
• Cerivastatin
• Cholera Vaccine, Live
• Cholic Acid
• Choline Salicylate
• Cimetidine
• Ciprofibrate
• Ciprofloxacin
• Clarithromycin
• Clofazimine
• Clofibrate
• Clonixin
• Clopidogrel
• Clozapine
• Cobicistat
• Codeine
• Conivaptan
• Crizotinib
• Cyclophosphamide
• Dabigatran Etexilate
• Dabrafenib
• Daclatasvir
• Daridorexant
• Darunavir
• Dasabuvir
• Deflazacort
• Delavirdine
• Dengue Tetravalent Vaccine, Live
• Desogestrel
• Dexamethasone
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Dienogest
• Diflunisal
• Digoxin
• Dihydrocodeine
• Diltiazem
• Dipyrone
• Domperidone
• Donepezil
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Drospirenone
• Droxicam
• Duvelisib
• Ebola Zaire Vaccine, Live
• Edoxaban
• Efavirenz
• Elacestrant
• Elexacaftor
• Eluxadoline
• Enalaprilat
• Enalapril Maleate
• Enasidenib
• Encorafenib
• Entrectinib
• Enzalutamide
• Eplerenone
• Eprosartan
• Erdafitinib
• Erythromycin
• Eslicarbazepine Acetate
• Estetrol
• Estradiol
• Ethinyl Estradiol
• Ethynodiol
• Etodolac
• Etofenamate
• Etoposide
• Etoricoxib
• Etravirine
• Everolimus
• Fedratinib
• Felbinac
• Felodipine
• Fenofibrate
• Fenoprofen
• Fentanyl
• Fepradinol
• Feprazone
• Fexinidazole
• Finerenone
• Flibanserin
• Floctafenine
• Fluconazole
• Flufenamic Acid
• Flurbiprofen
• Fluvastatin
• Fluvoxamine
• Fosamprenavir
• Fosaprepitant
• Foscarnet
• Fosinopril
• Fosnetupitant
• Fosphenytoin
• Fostamatinib
• Gemfibrozil
• Gentamicin
• Gepirone
• Gestodene
• Gilteritinib
• Glecaprevir
• Hydrocodone
• Hydroxychloroquine
• Ibrexafungerp
• Ibrutinib
• Ibuprofen
• Idelalisib
• Imatinib
• Indinavir
• Indomethacin
• Infigratinib
• Infliximab
• Influenza Virus Vaccine, Live
• Irbesartan
• Isavuconazole
• Isavuconazonium Sulfate
• Istradefylline
• Itraconazole
• Ivacaftor
• Ivosidenib
• Ketoconazole
• Ketoprofen
• Ketorolac
• Lanreotide
• Lapatinib
• Larotrectinib
• Lasmiditan
• Lefamulin
• Lemborexant
• Lenacapavir
• Lesinurad
• Letermovir
• Levamlodipine
• Levonorgestrel
• Lisinopril
• Lorlatinib
• Lornoxicam
• Losartan
• Lovastatin
• Loxoprofen
• Lumacaftor
• Lumateperone
• Lumiracoxib
• Lurbinectedin
• Mavacamten
• Measles Virus Vaccine, Live
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Melphalan
• Meperidine
• Mestranol
• Methadone
• Methotrexate
• Methylprednisolone
• Metoclopramide
• Mibefradil
• Mirabegron
• Mitapivat
• Mitotane
• Mobocertinib
• Modafinil
• Moexipril
• Momelotinib
• Morniflumate
• Morphine
• Morphine Sulfate Liposome
• Mumps Virus Vaccine, Live
• Mycophenolate Mofetil
• Mycophenolic Acid
• Nabumetone
• Nafcillin
• Naproxen
• Nefazodone
• Nelfinavir
• Nepafenac
• Neratinib
• Netupitant
• Nevirapine
• Nicardipine
• Nifedipine
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Nirmatrelvir
• Nirogacestat
• Nomegestrol
• Norethindrone
• Norgestimate
• Norgestrel
• Obeticholic Acid
• Octreotide
• Olaparib
• Olmesartan
• Omaveloxolone
• Ombitasvir
• Osimertinib
• Oxaprozin
• Oxcarbazepine
• Oxycodone
• Oxyphenbutazone
• Ozanimod
• Pacritinib
• Palbociclib
• Palovarotene
• Parecoxib
• Paritaprevir
• Paroxetine
• Pazopanib
• Pemigatinib
• Pentazocine
• Perindopril
• Pexidartinib
• Phenobarbital
• Phenylbutazone
• Phenytoin
• Pibrentasvir
• Piketoprofen
• Piperaquine
• Piroxicam
• Pirtobrutinib
• Pixantrone
• Poliovirus Vaccine, Live
• Posaconazole
• Potassium Phosphate
• Pralsetinib
• Pranoprofen
• Pravastatin
• Primidone
• Proglumetacin
• Propafenone
• Propyphenazone
• Proquazone
• Pyrazinamide
• Quinapril
• Quinidine
• Quinine
• Ramipril
• Ranitidine
• Ranolazine
• Red Yeast Rice
• Relugolix
• Repotrectinib
• Revefenacin
• Ribociclib
• Rifabutin
• Rifampin
• Rifapentine
• Rimegepant
• Ritlecitinib
• Ritonavir
• Rivaroxaban
• Rofecoxib
• Roflumilast
• Rolapitant
• Rosuvastatin
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Rucaparib
• Salicylic Acid
• Salsalate
• Saquinavir
• Sarecycline
• Schisandra sphenanthera
• Selpercatinib
• Selumetinib
• Silodosin
• Simeprevir
• Sirolimus
• Sirolimus Protein-Bound
• Smallpox Monkeypox Vaccine, Live Non-Replicating
• Smallpox Vaccine
• Sodium Salicylate
• Sofosbuvir
• Sonidegib
• Sotorasib
• Sparsentan
• Spirapril
• Spironolactone
• St John's Wort
• Sufentanil
• Sulfamethoxazole
• Sulfinpyrazone
• Sulindac
• Suvorexant
• Tacrolimus
• Taurursodiol
• Tazemetostat
• Telaprevir
• Telithromycin
• Telmisartan
• Telotristat Ethyl
• Tenofovir Alafenamide
• Tenoxicam
• Tepotinib
• Terbinafine
• Tezacaftor
• Thioridazine
• Tiaprofenic Acid
• Ticagrelor
• Ticlopidine
• Tobramycin
• Tocilizumab
• Tofacitinib
• Tolfenamic Acid
• Tolmetin
• Tolvaptan
• Topotecan
• Tramadol
• Trandolapril
• Triamterene
• Trimethoprim
• Trofinetide
• Troleandomycin
• Tucatinib
• Typhoid Vaccine, Live
• Ubrogepant
• Ustekinumab
• Valdecoxib
• Valsartan
• Vancomycin
• Vandetanib
• Varicella Virus Vaccine, Live
• Velpatasvir
• Vemurafenib
• Venetoclax
• Venlafaxine
• Verapamil
• Vibegron
• Vilazodone
• Vincristine
• Vincristine Sulfate Liposome
• Voclosporin
• Vonoprazan
• Vorapaxar
• 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
• Amiodarone
• Amphotericin B Cholesteryl Sulfate Complex
• Amphotericin B Lipid Complex
• Amphotericin B Liposome
• Chloramphenicol
• Chloroquine
• Cisapride
• Clonidine
• Colesevelam
• Dalfopristin
• Danazol
• Dirithromycin
• Famotidine
• Furosemide
• Glipizide
• Glyburide
• Imipenem
• Josamycin
• Metronidazole
• Midazolam
• Miokamycin
• Norfloxacin
• Oxypurinol
• Probucol
• Quinupristin
• Repaglinide
• Sulfadiazine
• Sulfasalazine
• Tigecycline
• Tolterodine
• Troglitazone
• Warfarin

Other interactions—

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 is usually not recommended, 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

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse, or history of, or
• Epilepsy (seizures) or
• Liver disease—This medicine contains alcohol, which can make these conditions worse.

• Allergy to polyoxyethylated castor oil (Cremophor® EL)—Should not be used in patients with this condition.

• Anemia or
• Bleeding problems or
• Brain disease (eg, encephalopathy) or
• Cancer or
• Eye or visual problems (eg, papilloedema) or
• Hyperkalemia (high potassium in the blood) or
• Hypertension (high blood pressure) or
• Hyperuricemia (too much uric acid in the blood) or
• Infection (eg, bacteria, fungus, virus) or
• Kidney disease or
• Liver disease or
• Lymphoma (cancer of the lymph glands) or
• Seizures, history of or
• Skin cancer or
• Thrombocytopenia (low number of platelets)—Use with caution. May make these conditions worse. .

• Hypertension (high blood pressure) or
• Hypocholesterolemia (low cholesterol in the blood) or
• Hypomagnesemia (low magnesium in the blood)—May increase risk for encephalopathy.

• Infection—May decrease body's ability to fight infection.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine. This medicine is given through an IV placed in one of your veins.

This medicine is usually given 4 to 12 hours before organ transplantation. Then your doctor will switch you to the oral (by mouth) form of Sandimmune®.

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

Precautions While Using This Medicine:

It is very important that your doctor check you closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. 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.

This medicine may cause a serious allergic reaction, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Check with your doctor right away if you have chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, skin rash, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, trouble breathing, or unusual tiredness or weakness.

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.

Hyperkalemia (high potassium in the blood) may occur while you are receiving this medicine. Tell your doctor right away if you have confusion, difficulty breathing, irregular heartbeat, nausea or vomiting, nervousness, numbness or tingling in the hands, feet, or lips, stomach pain, trouble breathing, or weakness or heaviness of the legs. 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 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 swelling, 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.

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

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 receiving 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.

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 lowers your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. However, it may be especially important to receive certain immunizations to prevent a disease. In addition, other persons living in your house should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid persons who have recently taken oral polio vaccine. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

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 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.

Side Effects of This Medicine:

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 or nurse immediately if any of the following side effects occur:

More common

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

fever

headache

itching

loss of appetite

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

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

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

Incidence not known

Back pain

drowsiness

headache, severe and throbbing

muscle spasms (tetany) or twitching

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 or nervousness

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.