Abatacept

Generic name: Abatacept

Usage of Abatacept

Abatacept (Orencia) is used to treat rheumatoid arthritis (RA), psoriatic arthritis (PsA), and polyarticular juvenile idiopathic arthritis (pJIA), which are autoimmune disorders, and is also used to prevent acute graft versus host disease (aGVHD). Abatacept works by preventing your body's immune system from attacking healthy tissues or graft tissues. 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 a selective T-cell costimulation modulator.

T cells (T lymphocytes) are a type of white blood cell that is part of the immune system, activated T cells are involved in autoimmune disorders such as RA, pJIA, and PsA. Abatacept blocks T cells from becoming activated by binding to proteins on the cell surface called CD80 and CD86, which block interaction with a protein called CD28. This means the T cells are not fully activated, so helps relieve symptoms of RA, pJIA, PsA, and acute graft versus host disease.

Abatacept is not a cure for any autoimmune disorder and will only treat the symptoms of your condition.

Abatacept became an FDA-approved medicine on December 23, 2005.

Abatacept side effects

Common abatacept side effects

fever

nausea, diarrhea, stomach pain

headache

cold symptoms such as stuffy nose, sneezing, sore throat, or cough.

Serious abatacept side effects

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

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.

You may get infections more easily, even serious or fatal infections. 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.

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.

Before taking Abatacept

You should not use abatacept if you are allergic to it or any of the in

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.

Tell your doctor if you have ever had:

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;

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.

Children using abatacept should be current on all childhood immunizations before starting treatment.

Pregnancy

Tell your healthcare provider if you are pregnant, become pregnant, or plan to become pregnant, as it is not known if abatacept can harm your unborn baby. If you take abatacept during pregnancy, your name may be listed on a pregnancy registry to track the effects of abatacept on the baby.

Breastfeeding

Tell your doctor if you are pregnant or breastfeeding. It is not known if abatacept passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you use abatacept

How to use Abatacept

Usual Adult Dose for Rheumatoid Arthritis:

IV Dosing Regimen: Weight less than 60 kg: 500 mg IV initially, at 2 and 4 weeks, and every 4 weeks thereafter. Weight 60 to 100 kg: 750 mg IV initially, at 2 and 4 weeks, and every 4 weeks thereafter. Weight more than 100 kg: 1000 mg IV initially, at 2 and 4 weeks, and every 4 weeks thereafter. Subcutaneous Dosing Regimen: Optional IV loading dose:

Weight less than 60 kg: 500 mg IV once.

Weight 60 to 100 kg: 750 mg IV once.

Weight more than 100 kg: 1000 mg IV once

Subcutaneous injection: 125 mg subcutaneously once a week Comments: This drug may be used as monotherapy or concomitantly with disease-modifying antirheumatic drugs (DMARDs) other than Janus kinase (JAK) inhibitors or biologic disease-modifying antirheumatic drugs (bDMARDS), such as tumor necrosis factor (TNF) antagonists. The IV infusion should be administered over 30 minutes. Before the first subcutaneous dose, an optional loading dose may be administered as a single IV infusion; if an IV loading dose is used, the first subcutaneous injection should be administered within 1 day of the infusion. For patients switching from IV therapy to subcutaneous administration, the first subcutaneous dose should be administered instead of the next scheduled IV dose. Use: For the treatment of patients with moderately to severely active rheumatoid arthritis

Usual Adult Dose for Psoriatic Arthritis:

IV Dosing Regimen: Weight less than 60 kg: 500 mg IV initially, at 2 and 4 weeks, and every 4 weeks thereafter Weight 60 to 100 kg: 750 mg IV initially, at 2 and 4 weeks, and every 4 weeks thereafter Weight more than 100 kg: 1000 mg IV initially, at 2 and 4 weeks, and every 4 weeks thereafter Subcutaneous Dosing Regimen: 125 mg subcutaneously once a week Comments: This drug may be used with or without nonbiologic DMARDs. The IV infusion should be administered over 30 minutes. For patients switching from IV therapy to subcutaneous administration, the first subcutaneous dose should be administered instead of the next scheduled IV dose. Use: For the treatment of patients with active psoriatic arthritis

Usual Adult Dose for Graft Versus Host Disease - Prophylaxis:

10 mg/kg IV on the day before transplantation (Day -1), then 10 mg/kg IV on Days 5, 14, and 28 after transplantation Maximum dose: 1000 mg/dose Comments: Before administering this drug, recommended antiviral prophylaxis for Epstein-Barr virus (EBV) reactivation should be administered and continued for 6 months after hematopoietic stem cell transplantation (HSCT); additionally, prophylactic antivirals for CMV infection/reactivation should be considered during therapy and for 6 months after HSCT. The IV infusion should be administered over 60 minutes. Use: In combination with a calcineurin inhibitor and methotrexate, for the prophylaxis of acute graft versus host disease (aGVHD) in patients undergoing HSCT from a matched or 1 allele-mismatched unrelated-donor

Usual Pediatric Dose for Juvenile Idiopathic Arthritis:

IV Dosing Regimen: 6 years or older: Weight less than 75 kg: 10 mg/kg IV initially, at 2 and 4 weeks, and every 4 weeks thereafter Weight 75 to 100 kg: 750 mg IV initially, at 2 and 4 weeks, and every 4 weeks thereafter Weight more than 100 kg: 1000 mg IV initially, at 2 and 4 weeks, and every 4 weeks thereafter Maximum dose: 1000 mg/dose Subcutaneous Dosing Regimen: 2 years or older: Weight 10 to less than 25 kg: 50 mg subcutaneously once a week Weight 25 to less than 50 kg: 87.5 mg subcutaneously once a week Weight at least 50 kg: 125 mg subcutaneously once a week Comments: This drug may be used as monotherapy or concomitantly with methotrexate. The IV infusion should be administered over 30 minutes. Subcutaneous administration: Patients may self-inject or the patient's caregiver may administer this drug if both the health care provider and parent/legal guardian decides it is appropriate; the ability of pediatric patients to self-inject with the autoinjector has not been tested. Use: For the treatment of patients with moderately to severely active polyarticular juvenile idiopathic arthritis

Usual Pediatric Dose for Graft Versus Host Disease - Prophylaxis:

2 to less than 6 years: 15 mg/kg IV on the day before transplantation (Day -1), then 12 mg/kg IV on Days 5, 14, and 28 after transplantation 6 years or older: 10 mg/kg IV on the day before transplantation (Day -1), then 10 mg/kg IV on Days 5, 14, and 28 after transplantation Maximum dose: 1000 mg/dose Comments: Before administering this drug, recommended antiviral prophylaxis for EBV reactivation should be administered and continued for 6 months after HSCT; additionally, prophylactic antivirals for CMV infection/reactivation should be considered during therapy and for 6 months after HSCT. The IV infusion should be administered over 60 minutes. Use: In combination with a calcineurin inhibitor and methotrexate, for the prophylaxis of aGVHD in patients undergoing HSCT from a matched or 1 allele-mismatched unrelated-donor.

Warnings

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Using abatacept with a TNF antagonist, other biologic RA/PsA therapy, or JAK Inhibitors can increase the risk of infections and serious infections.

Hypersensitivity and anaphylaxis have occurred.

Serious infections have been reported. Patients with a history of recurrent infections or underlying conditions predisposing to infections may experience more infections. Discontinue if a serious infection develops.

Screen for latent tuberculosis (TB) infection before starting abatacept therapy. Patients testing positive should be treated for TB before starting abatacept treatment.

You should be screened for viral hepatitis before starting abatacept.

Update vaccinations before starting treatment. Live vaccines should not be given concurrently or within 3 months of discontinuation. Abatacept may blunt the effectiveness of some immunizations.

Chronic obstructive pulmonary disease (COPD) patients may develop more frequent respiratory adverse events.

Cytomegalovirus (CMV) and Epstein-Barr Virus (EBV) reactivation in patients treated for aGVHD prophylaxis.

What other drugs will affect Abatacept

Tell your doctor about all your other medicines, especially:

adalimumab;

anakinra;

certolizumab;

etanercept;

golimumab;

infliximab;

rituximab; or

tocilizumab.

This list is not complete. Other drugs may affect abatacept, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

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