Simulect

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Simulect is a prescription medication that is used with cyclosporine and corticosteroids to prevent immediate transplant rejection (attack of the transplanted organ by the immune system of the person receiving the organ) in people who are receiving kidney transplants.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

You should not use basiliximab if you are allergic to it.

Before you receive this medicine, tell your doctor if you have cancer, diabetes, high cholesterol, or high or low levels of potassium in your blood.

Basiliximab can lower blood cells that help your body fight infections and help your blood clot. Your blood may need to be tested often. Avoid being near people who are sick or have infections. Avoid activities that may increase your risk of bleeding injury. Tell your doctor at once if you develop signs of infection.

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.

Avoid receiving a vaccine shortly after you have been treated with basiliximab, unless your doctor has told you to.

There may be other drugs that can interact with basiliximab. 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.

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

Avoid receiving a vaccine shortly after you have been treated with basiliximab, unless your doctor has told you to.

Tell your doctor about all other medicines you use, especially:

• chemotherapy or radiation;

• steroid medicine;

• sirolimus (Rapamune), tacrolimus (Prograf);

• muromonab-CD3 (Orthoclone);

• mycophenolate mofetil (CellCept); or

• azathioprine (Azasan, Imuran), leflunomide (Arava), etanercept (Enbrel).

This list is not complete and other drugs may interact with basiliximab. 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.

Specific Drugs

• Importance of understanding potential benefits of basiliximab and risks of immunosuppressive therapy.1

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs as well as any concomitant illnesses.1

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

• Importance of informing patients of other important precautionary information. (See Cautions.)

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

Studies on the use of basiliximab in children have not been completed. Preliminary information on the use of basiliximab in children suggests children have the same side effects from receiving basiliximab as those experienced by adult patients, and basiliximab works as well to prevent rejection of the transplanted kidney in children as it does in adult patients.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way as they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of basiliximab in the elderly with use in other age groups.

Pregnancy

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 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 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.

• Echinacea

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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:

• Cancer—Basiliximab may make this condition worse

• Infection—Basiliximab may decrease the body's ability to fight infection

Use Simulect as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as an infusion into a vein over a period of time.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

Simulect® (basiliximab) is supplied in a single-use glass vial.

Each carton contains one of the following

1 Simulect 10 mg vial…………………………………………………….NDC 0078-0393-61

1 Simulect 20 mg vial…………………………………………………….NDC 0078-0331-84

Store lyophilized Simulect under refrigerated conditions (2ºC to 8ºC; 36ºF to 46ºF).

Do not use beyond the expiration date stamped on the vial.

Applies to basiliximab: intravenous powder for solution

Along with its needed effects, basiliximab (the active ingredient contained in Simulect) 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 as soon as possible if any of the following side effects occur while taking basiliximab:

• Abdominal pain
• back pain
• coughing
• dizziness
• fever or chills
• loss of energy or weakness
• painful urination
• shortness of breath
• sore throat
• swelling of the ankles, body, face, feet or lower legs
• trembling or shaking of the hands or feet
• vomiting
• white patches in the mouth or throat or on the tongue

• Abnormal vision
• agitation
• anxiety
• bleeding, tender, or enlarged gums
• blood in the stool
• bruising
• chest pain
• depression
• difficulty in urinating
• fatigue
• itching
• numbness or pain in the legs
• skin rash
• sores in the mouth
• “stocking and gloves” sensation of the hands or feet
• tingling

Some side effects of basiliximab 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:

• Acne
• constipation
• diarrhea
• headache
• heartburn
• nausea
• trouble in sleeping
• weight gain

• Excessive hair growth
• joint pain
• muscle pain

Applies to basiliximab: intravenous powder for injection

Gastrointestinal

Gastrointestinal side effects have been reported in 75% of treated patients (vs 73% in placebo treated patients), making them the most frequently reported side effect with the use of basiliximab (the active ingredient contained in Simulect) Other gastrointestinal effects including constipation, nausea, diarrhea, abdominal pain, vomiting, dyspepsia, and moniliasis have been reported in at least 10% of patients. Enlarged abdomen, flatulence, gastrointestinal disorder, gastroenteritis, GI hemorrhage, gum hyperplasia, melena, esophagitis, and ulcerative stomatitis have been reported in between 3% and 10% of patients.[Ref]

Hypersensitivity

Hypersensitivity side effects including seventeen cases of severe acute hypersensitivity reactions (including anaphylaxis) have been reported. Reactions may include hypotension, tachycardia, cardiac failure, dyspnea, wheezing, bronchospasm, pulmonary edema, respiratory failure, urticaria, rash, pruritus, and/or sneezing.[Ref]

If a severe hypersensitivity reaction occurs, it is recommended that therapy with basiliximab be permanently discontinued.[Ref]

Metabolic

Metabolic side effects including hyperkalemia, hypokalemia, hyperglycemia, hyperuricemia, hypophosphatemia, hypocalcemia, weight increase, hypercholesterolemia, and acidosis have been reported in at least 10% of patients. Dehydration, diabetes mellitus, fluid overload, hypercalcemia, hyperlipidemia, hypoglycemia, hypoproteinemia, and hypomagnesemia have been reported in between 3% and 10% of patients.[Ref]

Nervous system

Nervous system side effects including headache, tremor, and dizziness have been reported in at least 10% of patients. Hypoesthesia, neuropathy, and paraesthesia have been reported in between 3% and 10% of patients.[Ref]

Genitourinary

Genitourinary side effects including dysuria, increased nonprotein nitrogen, and urinary tract infection have been reported in at least 10% of patients. Male genital edema, impotence, albuminuria, bladder disorder, hematuria, frequent micturition, oliguria, abnormal renal function, renal tubular necrosis, surgery, urethral disorder, and urinary retention have been reported in between 3% and 10% of patients.[Ref]

General

General side effects including pain, peripheral edema, edema, fever, viral infection, leg edema, and asthenia have been reported in at least 10% of patients. Accidental trauma, chest pain, increased drug level, face edema, fatigue, infection, malaise, generalized edema, rigors, and sepsis have been reported in between 3% and 10% of patients.[Ref]

Cardiovascular

Cardiovascular side effects including hypertension have been reported in at least 10% of patients. Angina pectoris, cardiac failure, chest pain, abnormal heart sounds, aggravated hypertension, arrhythmia, atrial fibrillation, tachycardia, vascular disorder, and hypotension have been reported in between 3% and 10% of patients.[Ref]

Respiratory

Respiratory side effects including dyspnea, upper respiratory tract infection, coughing, rhinitis, and pharyngitis have been reported in at least 10% of patients. Bronchitis, bronchospasm, abnormal chest sounds, pneumonia, pulmonary disorder, pulmonary edema, and sinusitis have been reported in between 3% and 10% of patients.[Ref]

Dermatologic

Dermatologic side effects including surgical wound complications and acne have been reported in at least 10% of patients. Cyst, herpes simplex, herpes zoster, hypertrichosis, pruritus, rash, skin disorder, and skin ulceration have been reported in between 3% and 10% of patients.[Ref]

Psychiatric

Psychiatric side effects including insomnia have been reported in at least 10% of patients. Agitation, anxiety, and depression have been reported in between 3% and 10% of patients.[Ref]

Musculoskeletal

Musculoskeletal side effects including leg pain and back pain have been reported in at least 10% of patients. Arthralgia, arthropathy, bone fractures, cramps, hernia, and myalgia have been reported in between 3% and 10% of patients.[Ref]

Hematologic

Hematologic side effects including anemia have been reported in at least 10% of patients. Hematoma, hemorrhage, purpura, thrombocytopenia, polycythemia, and thrombosis have been reported in between 3% and 10% of patients.[Ref]

Endocrine

Endocrine side effects including increased glucocorticoids have been reported in between 3% and 10% of patients.[Ref]

Ocular

Ocular side effects including cataract, conjunctivitis, and abnormal vision have been reported in between 3% and 10% of patients.[Ref]

Some side effects of Simulect may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.