SandIMMUNE (Intravenous)

Cyclosporine injection is used together with other medicines (for example, steroid medicines) to stop the body from rejecting a transplanted organ (such as a kidney, liver, or heart). It is part of a group of medicines called immunosuppressive agents. After an organ transplant, the body's white blood cells may try to reject the new organ. Cyclosporine helps by suppressing the immune system, which prevents the white blood cells from rejecting the transplanted organ.

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

It is very important for your doctor to monitor you closely while you are receiving this medicine. This will help your doctor see if the medicine is working as it should and decide if you should continue taking it. You may need blood and urine tests to check for unwanted effects.

You will also need to have your blood pressure checked before starting this medicine and while you are using it. If you notice any changes in your blood pressure, call your doctor immediately. If you have any questions about this, speak with your doctor.

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

Contact your doctor immediately if you notice blood in your urine, changes in how often you urinate or how much urine you produce, difficulty breathing, drowsiness, increased thirst, loss of appetite, nausea or vomiting, swelling in your feet or lower legs, or weakness. These may be signs of a serious kidney issue.

Hyperkalemia (high potassium levels in the blood) may happen while you are receiving this medicine. Tell your doctor right away if you experience confusion, difficulty breathing, irregular heartbeat, nausea or vomiting, nervousness, numbness or tingling in your hands, feet, or lips, stomach pain, trouble breathing, or weakness or heaviness in your legs. Do not use potassium supplements or salt substitutes without first checking with your doctor.

Contact your doctor immediately if you have pain or tenderness in your upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellowing of your eyes or skin. These could indicate a serious liver problem.

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

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

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

This medicine may raise your chances of getting infections. Try to avoid being around people who are sick while you are receiving this medicine. Wash your hands often. Inform your doctor if you have any kind of infection before starting this medicine. Let your doctor know if you have ever had an infection that did not go away or one that kept coming back.

If you are taking this medicine after a kidney transplant, it may increase your risk for rare and serious viral infections, such as polyoma virus-associated nephropathy (PVAN), progressive multifocal leukoencephalopathy (PML), and BK virus-associated nephropathy (BKVAN). The BK virus can affect your kidney function and cause a transplanted kidney to fail. Contact your doctor immediately if you have bloody urine, decreased urination, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, difficulty breathing, unusual tiredness or weakness, vomiting, or weight gain.

Tell your doctor immediately if you experience seizures, headaches, confusion, vision problems, unusual drowsiness, tiredness, or weakness. These could be signs of a serious nervous system issue known as posterior reversible encephalopathy syndrome (PRES).

While you are being treated with cyclosporine, and after you stop treatment, do not receive any immunizations (vaccines) without your doctor's approval. Cyclosporine lowers your body's resistance to infections, so there is a chance you could get the infection that the immunization is meant to prevent. However, it may be particularly important to receive certain immunizations to prevent disease. Additionally, others in your household should avoid taking the oral polio vaccine, as they could pass the virus to you. Also, keep away from individuals who have recently taken the oral polio vaccine. Do not stay in the same room with them for long. If you cannot take these precautions, consider wearing a protective face mask covering your nose and mouth.

In some patients (usually younger ones), tenderness, swelling, or bleeding of the gums may occur shortly after starting treatment with cyclosporine. Brushing and flossing your teeth regularly and gently massaging your gums may help prevent this. See your dentist regularly for cleanings. Ask your medical doctor or dentist if you have questions about dental care, 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 you have discussed them with your doctor. This includes prescription or over-the-counter (OTC) medicines, as well as herbal supplements (like St. John's wort) or vitamin supplements.

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

Allergies

Inform your clinician if you have ever had any unusual or allergic reaction to this medication or any other drugs. Additionally inform 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 injection have not been performed in the pediatric population. Nevertheless, no pediatric-specific issues have been documented to date.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific issues that would limit the usefulness of cyclosporine injection in the elderly. Nevertheless, 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 chance when using this medication during breastfeeding. Weigh the potential benefits against the potential risks prior to taking this medicine while breastfeeding.

Interactions with Drugs

Although certain medications should not be used together at all, in other cases two different medications may be used together even if an interaction might occur. In these cases, your physician may want to change the dose, or other precautions may be necessary. When you are receiving this medication, it is especially critical that your healthcare professional know if you are using 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 medication with any of the following medicines is not recommended. Your clinician may decide not to treat you with this medication or change some of the other drugs you take.

• Bosentan
• Colchicine
• Dronedarone
• Elagolix
• Eliglustat
• Grazoprevir
• Lercanidipine
• Levoketoconazole
• Mifepristone
• Pitavastatin
• Simvastatin
• Sitaxsentan

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

• 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
• 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 medication with any of the following medicines may cause an increased risk of certain adverse effects, but using both drugs may be the best therapy for you. If both medications are prescribed together, your clinician may change the dose or how frequently 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
• Boceprevir
• Bromocriptine
• Chloramphenicol
• Chloroquine
• Cimetidine
• Ciprofloxacin
• Cisapride
• Clarithromycin
• Clonidine
• Colesevelam
• Dalfopristin
• Danazol
• Digoxin
• Dirithromycin
• Erythromycin
• Famotidine
• Fenofibrate
• Fluvoxamine
• Fosamprenavir
• Fosphenytoin
• Furosemide
• Glipizide
• Glyburide
• Imipenem
• Indinavir
• Josamycin
• Ketoconazole
• Methylprednisolone
• Metronidazole
• Mibefradil
• Midazolam
• Miokamycin
• Modafinil
• Nefazodone
• Nelfinavir
• Nevirapine
• Norfloxacin
• Oxypurinol
• Phenytoin
• Probucol
• Propafenone
• Quinine
• Quinupristin
• Repaglinide
• Rifapentine
• Saquinavir
• Sulfadiazine
• Sulfasalazine
• Suvorexant
• Terbinafine
• Tigecycline
• Tobramycin
• Tolterodine
• Troglitazone
• Verapamil
• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medications 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 drugs may also cause interactions to occur. Discuss with your healthcare professional the use of your drug with food, alcohol, or tobacco.

Other Medical Issues

The presence of other medical issues may affect the use of this medication. Make sure you tell your clinician 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 raise chance for encephalopathy.

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

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.

In the U.S.

• SandIMMUNE

Available Dosage Forms:

• Solution

Therapeutic Class: Immune Suppressant

Pharmacologic Class: Calcineurin Inhibitor

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.

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