SandIMMUNE

Name: SandIMMUNE

Adverse Effects

>10%

Tremor (12-55%)

Nephrotoxicity (32%)

Hypertension (26%)

Infection (3-25%)

Headache (2-25%)

Nausea (23%)

Hirsutism (21%)

Hypertrichosis (5-19%)

Female reproductive disorder (5-19%)

Gum hyperplasia (2-16%)

Triglycerides increased (15%)

Abdominal discomfort (1-15%)

URI (1-14%)

Diarrhea (3-13%)

Dyspepsia (2-12%)

Leg cramps (2-12%)

Parathesia (1-11%)

1-10%

Acne

Convulsions

Pruitus

Hyperkalemia, hypomagnesemia

Pancreatitis

Hepatotoxicity

Flu-like syndrome

Frequency Not Defined

Leukopenia

Thrombocytopenia

Anaphylaxis

Glomerular capillary thrombosis

Hypomagnesemia

Migraine

Hyponatremia

Postmarketing Reports

Pain in lower extremities

What is the most important information i should know about cyclosporine (gengraf, neoral, sandimmune)?

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.

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.

Sandimmune Precautions

  • Sandimmune is available in the original form of cyclosporine. Original cyclosporine and cyclosporine (modified) are absorbed by the body in different amounts, so they cannot be substituted for one another. Take only the type of cyclosporine that was prescribed by your doctor. When your doctor gives you a written prescription, check to be sure that he or she has specified the type of cyclosporine you should receive. Each time you have your prescription filled, look at the brand name printed on your prescription label to be sure that you have received the same type of cyclosporine. Talk to your pharmacist if the brand name is unfamiliar or you are not sure you have received the right type of cyclosporine.
  • Taking Sandimmune may increase the risk that you will develop an infection or cancer, especially lymphoma (cancer of a part of the immune system) or skin cancer. This risk may be higher if you take Sandimmune with other medications that decrease the functioning of the immune system such as azathioprine (Imuran), cancer chemotherapy, methotrexate (Rheumatrex), sirolimus (Rapamune), and tacrolimus (Prograf). Tell your doctor if you are taking any of these medications, and if you have or have ever had any type of cancer. To reduce your risk of skin cancer, plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen during your treatment. If you experience any of the following symptoms, call your doctor immediately:
    • sore throat
    • fever
    • chills and other signs of infection
    • flu-like symptoms
    • coughing
    • difficulty urinating
    • pain when urinating
    • a red, raised, or swollen area on the skin
    • new sores or discoloration on the skin
    • lumps or masses anywhere in your body
    • night sweats
    • swollen glands in the neck, armpits, or groin
    • trouble breathing
    • chest pain
    • weakness or tiredness that does not go away
    • pain, swelling, or fullness in the stomach
  • Sandimmune may cause high blood pressure and kidney damage. Tell your doctor if you have or have ever had high blood pressure or kidney disease. If you experience any of the following symptoms, call your doctor immediately:
    • dizziness
    • swelling of the arms, hands, feet, ankles, or lower legs
    • fast, shallow breathing
    • nausea
    • irregular heartbeat
  • Sandimmune may cause growth of extra tissue in your gums. Be sure to brush your teeth carefully and see a dentist regularly during your treatment to decrease the risk that you will develop this side effect.
  • Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to Sandimmune.

 

Sandimmune Overdose

If you take too much Sandimmune, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Sandimmune is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Sandimmune (cyclosporine) side effects

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

Call your doctor at once if you have:

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

  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

  • pale or yellowed skin, dark colored urine, fever, confusion or weakness;

  • dangerously high blood pressure--severe headache, blurred vision, pounding in your neck or ears, nosebleed, anxiety, confusion, severe chest pain, shortness of breath, irregular heartbeats;

  • high potassium--nausea, slow or unusual heart rate, weakness, loss of movement;

  • kidney problems--little or no urinating, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath;

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

  • signs of infection--fever, chills, flu-like symptoms, mouth sores, skin sores, feeling light-headed or short of breath, rapid heart rate.

Common side effects may include:

  • tremors or shaking;

  • acne, increased growth of facial or body hair;

  • increased blood pressure;

  • nausea, diarrhea; or

  • swollen or painful gums.

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.

What other drugs will affect Sandimmune (cyclosporine)?

Cyclosporine can harm your kidneys. This effect is increased when you also use certain other medicines, including: antivirals, cholesterol-lowering drugs, chemotherapy, injected antibiotics, medicine for bowel disorders, medicines to treat autoimmune disorders, medicine to prevent organ transplant rejection, stomach acid reducers (Tagamet, Zantac), and some pain or arthritis medicines (including aspirin, Tylenol, Advil, and Aleve).

Many drugs can interact with cyclosporine. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, especially:

  • ambrisentan or bosentan;

  • dabigatran;

  • rifabutin;

  • St. John's wort;

  • antibiotic or antifungal medicine;

  • antiviral medicine to treat hepatitis C or HIV/AIDS;

  • birth control pills;

  • cholesterol-lowering medication:

  • heart or blood pressure medication, including a diuretic or "water pill";

  • seizure medication; or

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

This list is not complete and many other drugs can interact with cyclosporine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Precautions While Using Sandimmune

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.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include changes in color of the skin of the face, very fast but irregular heartbeat or pulse, hive-like swellings on the skin, flushing of the face, and puffiness or swellings of the eyelids or around the eyes. If these side effects occur, get emergency help at once.

Check with your doctor right away if you have any of the following symptoms: 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 the following symptoms: abdominal or stomach pain, confusion, difficulty breathing, irregular heartbeat, nausea or vomiting, nervousness, numbness or tingling in the hands, feet, or lips, shortness of breath, 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 increase your risk of getting skin cancer or cancer of the lymph system (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.

This medicine may increase your risk of developing rare and serious virus infections, such as progressive multifocal leukoencephalopathy (PML) and polyoma virus-associated nephropathy (PVAN). The BK virus may affect how your kidneys work and cause a transplanted kidney to fail. Check with your doctor right away if you are having more than one of these symptoms: 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.

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.

Grapefruit and grapefruit juice may increase the effects of cyclosporine by increasing the amount of this medicine in the body. You should not eat grapefruit or drink grapefruit juice while you are receiving this medicine.

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

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

More common
  • Abdominal or stomach pain or tenderness
  • 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
  • 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
Less common
  • 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
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
  • 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
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.

Laboratory Tests

Renal and liver functions should be assessed repeatedly by measurement of BUN, serum creatinine, serum bilirubin, and liver enzymes.

Overdosage

There is a minimal experience with overdosage. Because of the slow absorption of Sandimmune Soft Gelatin Capsules or Oral Solution, forced emesis and gastric lavage would be of value up to 2 hours after administration. Transient hepatotoxicity and nephrotoxicity may occur which should resolve following drug withdrawal. Oral doses of cyclosporine up to 10 g (about 150 mg/kg) have been tolerated with relatively minor clinical consequences, such as vomiting, drowsiness, headache, tachycardia and, in a few patients, moderately severe, reversible impairment of renal function. However, serious symptoms of intoxication have been reported following accidental parenteral overdosage with cyclosporine in premature neonates. General supportive measures and symptomatic treatment should be followed in all cases of overdosage. Sandimmune (cyclosporine) is not dialyzable to any great extent, nor is it cleared well by charcoal hemoperfusion. The oral LD50 is 2329 mg/kg in mice, 1480 mg/kg in rats, and >1000 mg/kg in rabbits. The intravenous (IV) LD50 is 148 mg/kg in mice, 104 mg/kg in rats, and 46 mg/kg in rabbits.

Principal display panel

Package Label – 25 mg

Rx Only             NDC 0078-0240-15

Sandimmune® Soft Gelatin Capsules

(cyclosporine capsules, USP)

30 Soft Gelatin Capsules

WARNING: Sandimmune® (cyclosporine capsules, USP) is

NOT BIOEQUIVALENT to Neoral® (cyclosporine capsules, USP) MODIFIED.

Do NOT use interchangeably without a physician’s supervision.

Each 25 mg capsule contains:

Cyclosporine, USP       25 mg

Alcohol, USP dehydrated       max 12.7% by volume

Inactive Ingredients: corn oil, gelatin, iron oxide red, linoleoyl macrogolglycerides, sorbitol, and titanium dioxide. May also contain glycerol.

Dosage:

See package insert for dosage information.

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