Drug: abatacept

abatacept Generic Name: abatacept (a BAY ta sept)
Brand Name: Orencia What is abatacept? Abatacept is a man-made protein that prevents your body's immune system from attacking healthy tissues such as joints. The immune system helps your body fight infections. In people with autoimmune disorders, the immune system mistakes the body's own cells for invaders and attacks them. Abatacept is used to treat the symptoms of rheumatoid arthritis, and to prevent joint damage caused by these conditions. It is also used to treat arthritis in children who are at least 6 years old. Abatacept is not a cure for any autoimmune disorder and will only treat the symptoms of your condition. Abatacept may also be used for purposes not listed in this medication guide. What is the most important information I should know about abatacept? You should not use abatacept if you are allergic to it, or if you are also using anakinra (Kineret), etanercept (Enbrel), adalimumab (Humira), certolizumab (Cimzia), golimumab (Simponi), infliximab (Remicade), natalizumab (Tysabri), rituximab (Rituxan), or tocilizumab (Actemra). What should I discuss with my healthcare provider before using abatacept? You should not use abatacept if you are allergic to it, or if you are also using anakinra (Kineret), etanercept (Enbrel), adalimumab (Humira), certolizumab (Cimzia), golimumab (Simponi), infliximab (Remicade), natalizumab (Tysabri), rituximab (Rituxan), or tocilizumab (Actemra). Before using abatacept, tell your doctor if you have ever had tuberculosis, if anyone in your household has tuberculosis, or if you have recently traveled to an area where tuberculosis is common. To make sure abatacept is safe for you, tell your doctor if you have: a weak immune system; any type of infection including a skin infection or open sores; infections that go away and come back; COPD (chronic obstructive pulmonary disease); diabetes; if you have ever had hepatitis; or if you are scheduled to receive any vaccines. Using abatacept may increase your risk of developing certain types of cancer such as lymphoma (cancer of the lymph nodes). This risk may be greater in older adults. Talk to your doctor about your specific risk. It is not known whether abatacept will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of abatacept on the baby. It is not known whether abatacept passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using this medicine. Children using abatacept should be current on all childhood immunizations before starting treatment. How should I use abatacept? Before you start treatment with abatacept, your doctor may perform tests to make sure you do not have tuberculosis or other infections. Abatacept is injected under the skin, or into a vein through an IV. You may be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, syringes, IV tubing, and other items used to inject the medicine. Abatacept must be given slowly when infected into a vein, and the IV infusion can take at least 30 minutes to complete. This medicine is usually given every 1 to 4 weeks. Follow your doctor's instructions. You may need to mix abatacept with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medication. Do not shake the medication bottle or you may ruin the medicine. Prepare your dose only when you are ready to give an injection. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine. Each single-use vial (bottle) or prefilled syringe of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose. Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets. If you need surgery, tell the surgeon ahead of time that you are using abatacept. If you have ever had hepatitis B, abatacept can cause this condition to come back or get worse. You will need frequent blood tests to check your liver function during treatment and for several months after you stop using this medicine. This medicine can cause false results with certain blood glucose tests, showing high blood sugar readings. If you have diabetes, talk to your doctor about the best way to check your blood sugar while you are using abatacept. Autoimmune disorders are often treated with a combination of different drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice. Store abatacept in the refrigerator. Do not freeze. Keep the medicine in original carton to protect it from light. Do not use abatacept if the expiration date on the medicine label has passed. If you need to transport the medicine, place the syringes in a cooler with ice packs. Abatacept that has been mixed with a diluent may be stored in a refrigerator or at room temperature and used within 24 hours. What happens if I miss a dose? Call your doctor for instructions if you miss your abatacept dose. What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What should I avoid while using abatacept? Do not receive a "live" vaccine while using abatacept, and for at least 3 months after your treatment ends. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine. Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection. Abatacept side effects Some side effects may occur during the injection. Tell your caregiver right away if you feel dizzy, light-headed, itchy, or have a severe headache or trouble breathing within 1 hour after receiving the injection. Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Serious and sometimes fatal infections may occur during treatment with abatacept. Stop using this medicine and call your doctor right away if you have signs of infection such as: fever, chills, night sweats, flu symptoms, weight loss; feeling very tired; dry cough, sore throat; or warmth, pain, or redness of your skin. Call your doctor at once if you have any of these other serious side effects: trouble breathing; stabbing chest pain, wheezing, cough with yellow or green mucus; pain or burning when you urinate; or signs of skin infection such as itching, swelling, warmth, redness, or oozing. Common side effects may include: fever; nausea, diarrhea, stomach pain; headache; or cold symptoms such as stuffy nose, sneezing, sore throat, cough. 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. See also: Side effects (in more detail) Abatacept dosing information Usual Adult Dose for Rheumatoid Arthritis:IV administration:
If less than 60 kg, give 500 mg
If 60 to 100 kg, give 750 mg
If greater than 100 kg, give 1000 mg
Administer once as a 30-minute intravenous infusion. The dose is repeated 2 and 4 weeks after the initial dose, then every 4 weeks thereafter. It may be administered alone or with disease-modifying antirheumatic drugs other than TNF antagonists.

Subcutaneous administration:
After a single IV infusion as a loading dose (as per body weight categories above), 125 mg administered by subcutaneous injection should be given within a day, followed by 125 mg subcutaneously once a week.
Patients who are unable to receive an infusion may initiate weekly injections subcutaneously without an intravenous loading dose.
Patients transitioning from IV therapy to subcutaneous administration should administer the first subcutaneous dose instead of the next scheduled intravenous dose.Usual Pediatric Dose for Juvenile Idiopathic Arthritis:Reduction of signs and symptoms in patients with moderately to severely active polyarticular juvenile idiopathic arthritis:
6 to 17 years:
If less than 75 kg, give 10 mg/kg IV
75 kg to 100 kg, give 750 mg IV
If greater than 100 kg, give 1000 mg IV

The maximum dose per intravenous administration should not exceed 1000 mg.

Administer once as a 30-minute intravenous infusion. The dose is repeated 2 and 4 weeks after the initial dose, then every 4 weeks thereafter. It may be administered alone or concomitantly with methotrexate. What other drugs will affect abatacept? Other drugs may interact with abatacept, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Source: http://www.drugs.com/

Not all side effects for abatacept may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here. For the ConsumerApplies to abatacept: powder for solution, solution In addition to its needed effects, some unwanted effects may be caused by abatacept. In the event that any of these side effects do occur, they may require medical attention. If any of the following side effects occur while taking abatacept, check with your doctor or nurse immediately: More common Back pain bladder pain bloody or cloudy urine body aches or pain chills cough cough producing mucus difficult or labored breathing difficult, burning, or painful urination dizziness ear congestion fever flu frequent urge to urinate headache loss of voice lower back or side pain nausea or vomiting noisy breathing pain or tenderness around the eyes and cheekbones shortness of breath or troubled breathing sneezing sore throat stuffy or runny nose tightness of the chest or wheezing unusual tiredness or weakness Less common Blurred vision burning or stinging of the skin chest pain nervousness painful cold sores or blisters on the lips, nose, eyes, or genitals pounding in the ears skin rash slow or fast heartbeat Rare Abdominal or stomach pain or tenderness confusion difficulty with swallowing dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position flushing hives or welts itching, pain, redness, swelling, tenderness, or warmth on the skin sweating swelling of the face, throat, or tongue Some of the side effects that can occur with abatacept may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional: More common Acid or sour stomach belching bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site heartburn indigestion stomach discomfort or upset Less common Diarrhea pain in the arms or legs For Healthcare ProfessionalsApplies to abatacept: intravenous powder for injection, subcutaneous solutionRespiratoryRespiratory side effects have included upper respiratory tract infection (5.8% to 12.7%), nasopharyngitis (7.8% to 11.5%), sinusitis (6.2%), bronchitis (5.8%), and pneumonia. Patients with COPD treated with abatacept developed adverse effects more frequently than those treated with placebo (97% vs. 88%, respectively). These have included COPD exacerbations, cough, rhonchi, dyspnea, and pneumonia. Bacterial pneumonia and influenzal pneumonia have been reported in 0.4% of patients.[Ref]HypersensitivityHypersensitivity side effects have included anaphylaxis or anaphylactoid reactions. Other adverse events potentially associated with drug hypersensitivity, such as hypotension, urticaria, and dyspnea generally occurred within 24 hours of abatacept infusion.[Ref]OncologicOncologic side effects have included lymphomas and lung cancer. Other malignancies included skin, breast, bile duct, bladder, cervical, endometrial, lymphoma, melanoma, myelodysplastic syndrome, ovarian, prostate, renal, thyroid, and uterine cancers.[Ref]GeneralGeneral side effects have included acute infusion-related adverse reactions occurring within one hour of the start of the infusion. The acute infusion-related events have included cardiopulmonary symptoms, such as hypotension, increased blood pressure, and dyspnea. The most frequently reported events were dizziness, headache, and hypertension. Other symptoms reported as mild to moderate included nausea, flushing, urticaria, cough, hypersensitivity, pruritus, rash, and wheezing. Back pain and pain in extremity have also been reported.[Ref]ImmunologicImmunologic side effects have included the development of binding antibodies to the entire abatacept molecule or to the CTLA-4 portion of abatacept. No correlation of antibody development to clinical response or adverse effects has been observed. Streptococcal sepsis (0.4%) has been reported.[Ref]GastrointestinalGastrointestinal side effects including nausea (6.6% to 11.5%), diarrhea (5.8% to 6.91%), diverticulitis (0.4%), peridiverticular abscess (0.4%), and dyspepsia have been reported.[Ref]GenitourinaryGenitourinary side effects have included urinary tract infection.[Ref]DermatologicDermatologic side effects have included rash.[Ref]Nervous systemNervous system side effects including headache (11.79%) have been reported.[Ref]LocalLocal side effects including infusion reactions have been reported.[Ref]OtherOther side effects have included limb abscess (0.4%).[Ref]

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Abatacept Pregnancy Warnings Abatacept has been assigned to pregnancy category C by the FDA. Animal studies have failed to reveal evidence of teratogenicity or fetotoxicity. Abatacept crosses the placenta. There are no controlled data in human pregnancy. Abatacept is only recommended for use during pregnancy when benefit outweighs risk. Rats treated with abatacept every three days during early gestation throughout the lactation period showed no adverse effects in the offspring at doses up to 45 mg/kg (3-fold a human 10 mg/kg dose based on AUC). At a dose of 200 mg/kg (11-fold a human 10 mg/kg dose based on AUC) alterations of immune function consisted of a 9-fold increase in the T-cell dependent antibody response in female pups and inflammation of the thyroid in one female pup out of 10 males and 10 females evaluated. It has not been determined if these findings indicate a risk for development of autoimmune diseases in humans exposed in utero to abatacept. A pregnancy registry has been established to monitor maternal-fetal outcomes of pregnant women exposed to abatacept. Healthcare professionals are encouraged to register patients and patients may also enroll themselves by calling 1-877-311-8972. Abatacept Breastfeeding Warnings There are no data on the excretion of abatacept into human milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, including possible effects on the developing immune system, a decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Source: http://www.drugs.com/

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