Abatacept

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

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 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.

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 affect the nursing baby. Tell your doctor if you are breast-feeding.

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

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Usual Adult Dose for Rheumatoid Arthritis:

IV:
-Less than 60 kg, give 500 mg
-If 60 to 100 kg, give 750 mg
-If greater than 100 kg, give 1000 mg
Administer as a 30-minute IV infusion; repeat the dose 2 and 4 weeks after the initial dose, then every 4 weeks thereafter.

SUBCUTANEOUS:
125 mg subcutaneously once a week with or without an IV loading dose
-For patients initiating therapy with an IV loading dose, begin therapy with a single IV infusion (as per body weight categories listed above) followed by the first 125 mg subcutaneous injection administered within a day of the IV infusion.

Comments:
-Patients transitioning from IV therapy to subcutaneous therapy should administer the first subcutaneous dose instead of the next scheduled IV dose.
-This drug should not be administered concomitantly with TNF antagonists or used concomitantly with other biologic rheumatoid arthritis (RA) therapy, such as anakinra.
-This drug may be administered alone or with disease-modifying antirheumatic drugs other than TNF antagonists.

Use: For reducing signs, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis

Usual Adult Dose for Psoriatic Arthritis:

IV:
-Less than 60 kg, give 500 mg
-If 60 to 100 kg, give 750 mg
-If greater than 100 kg, give 1000 mg
Administer as a 30-minute IV infusion; repeat the dose 2 and 4 weeks after the initial dose, then every 4 weeks thereafter.

SUBCUTANEOUS:
125 mg subcutaneously once a week (without an IV loading dose)

Comments:
-Patients transitioning from IV therapy to subcutaneous therapy should administer the first subcutaneous dose instead of the next scheduled IV dose.
-This drug should not be administered concomitantly with TNF antagonists or used concomitantly with other biologic rheumatoid arthritis (RA) therapy, such as anakinra.
-This drug may be administered alone or with disease-modifying antirheumatic drugs other than TNF antagonists.

Use: For the treatment of adult patients with active psoriatic arthritis (PsA)

Usual Pediatric Dose for Juvenile Idiopathic Arthritis:

IV:
6 years and older:
-If less than 75 kg: 10 mg/kg IV
-If 75 kg to 100 kg: 750 mg IV
-If greater than 100 kg: 1000 mg IV
-Maximum dose: 1000 mg
-Administer once as a 30-minute IV infusion; repeat at 2 and 4 weeks after the initial dose, then every 4 weeks thereafter

SUBCUTANEOUS:
2 years and older:
The subcutaneous injection should be given without an IV loading dose:
-If 10 kg to less than 25 kg: 50 mg subcutaneously once a week
-If 25 kg to less than 50 kg: 87.5 mg subcutaneously once a week
-If 50 kg or more: 125 mg subcutaneously once a week

Comments:
-Patients transitioning from IV therapy to subcutaneous therapy should administer the first subcutaneous dose instead of the next scheduled IV dose.
-This drug should not be administered concomitantly with TNF antagonists or used concomitantly with other biologic rheumatoid arthritis (RA) therapy, such as anakinra.
-This drug may be used as monotherapy or concomitantly with methotrexate.
-The safety and efficacy of the auto-injector for subcutaneous injection has not been studied in patients under 18 years of age.

Use: For pediatric patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis

• Inhibits T-cell activation by binding to CD80 and CD86, further blocking interaction with CD28.1 2 3 4 5

• Decreases T-cell proliferation and inhibits production of TNFα, interferon-γ and IL–2.1

• Suppresses inflammation, decreases anti-collagen antibody production, and reduces antigen specific production of interferon-γ.1

Uveitis (children/adolescents)

Results from case reports and noncontrolled data demonstrate that abatacept may be effective in treating uveitis in children and adolescents. However, the number of children studied is very low, and no controlled clinical trials have been performed. Abatacept has several safety concerns, including acute lymphocytic leukemia. Further data are needed to establish the efficacy, safety, optimal dosage, and length of abatacept therapy in the treatment of uveitis in children. An expert review panel considers abatacept to be a possible alternative in patients who are refractory to TNF-alpha blocking agents.

Signs and symptoms of infection, signs and symptoms of hypersensitivity reaction; hepatitis and TB screening prior to therapy initiation

Information related to the use of abatacept in pregnancy is limited (Kumar 2015). Until additional data are available, it is recommended to discontinue use and switch to a safer medication prior to conception unless no other pregnancy compatible medication is able to control maternal disease (Götestam Skorpen 2016).

A pregnancy registry has been established to monitor outcomes of women exposed to abatacept during pregnancy (1-877-311-8972).

The most common side effects of abatacept are:

• headache,
• upper respiratory tract infections and
• nausea.

Because abatacept depresses the immune system it reduces the body's ability to fight infection. Therefore, existing infections may worsen or new ones may develop.

Other important side effects include infusion-related reactions such as:

• dizziness,
• headache,
• hypotension,
• hypertension,
• nausea,
• wheezing,
• rash, and
• shortness of breath.

The most serious side effects are infections and cancer.

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Abatacept is a prescription medicine used alone or with other medications to reduce signs and symptoms in:

• adults with moderate to severe rheumatoid arthritis (RA), including those who have not been helped enough by other medicines for RA. In adults, abatacept may be used alone or with other RA treatments other than tumor necrosis factor (TNF) antagonists.
• children and adolescents 6 years of age and older with moderate to severe polyarticular juvenile idiopathic arthritis (JIA). Abatacept may be used alone or with methotrexate.
• adults with active psoriatic arthritis (PsA).

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

Abatacept is part of the drug class:

• Selective immunosuppressants

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of abatacept there are no specific foods that you must exclude from your diet when receiving abatacept.

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

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

IV:
-Less than 60 kg, give 500 mg
-If 60 to 100 kg, give 750 mg
-If greater than 100 kg, give 1000 mg
Administer as a 30-minute IV infusion; repeat the dose 2 and 4 weeks after the initial dose, then every 4 weeks thereafter.

SUBCUTANEOUS:
125 mg subcutaneously once a week with or without an IV loading dose
-For patients initiating therapy with an IV loading dose, begin therapy with a single IV infusion (as per body weight categories listed above) followed by the first 125 mg subcutaneous injection administered within a day of the IV infusion.

Comments:
-Patients transitioning from IV therapy to subcutaneous therapy should administer the first subcutaneous dose instead of the next scheduled IV dose.
-This drug should not be administered concomitantly with TNF antagonists or used concomitantly with other biologic rheumatoid arthritis (RA) therapy, such as anakinra.
-This drug may be administered alone or with disease-modifying antirheumatic drugs other than TNF antagonists.

Use: For reducing signs, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis

IV:
6 years and older:
-If less than 75 kg: 10 mg/kg IV
-If 75 kg to 100 kg: 750 mg IV
-If greater than 100 kg: 1000 mg IV
-Maximum dose: 1000 mg
-Administer once as a 30-minute IV infusion; repeat at 2 and 4 weeks after the initial dose, then every 4 weeks thereafter

SUBCUTANEOUS:
2 years and older:
The subcutaneous injection should be given without an IV loading dose:
-If 10 kg to less than 25 kg: 50 mg subcutaneously once a week
-If 25 kg to less than 50 kg: 87.5 mg subcutaneously once a week
-If 50 kg or more: 125 mg subcutaneously once a week

Comments:
-Patients transitioning from IV therapy to subcutaneous therapy should administer the first subcutaneous dose instead of the next scheduled IV dose.
-This drug should not be administered concomitantly with TNF antagonists or used concomitantly with other biologic rheumatoid arthritis (RA) therapy, such as anakinra.
-This drug may be used as monotherapy or concomitantly with methotrexate.
-The safety and efficacy of the auto-injector for subcutaneous injection has not been studied in patients under 18 years of age.

Use: For pediatric patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis

-No dosage adjustment is recommended in geriatric patients.
-No dosage adjustment is required when this drug is used in combination with other drugs (e.g., disease-modifying antirheumatic drugs (DMARDs), corticosteroids, NSAIDs) used to treat rheumatoid arthritis.
-Patients transitioning from IV to subcutaneous therapy should administer the first subcutaneous dose instead of the next scheduled monthly IV dose.

Data not available

Substance Name

Abatacept

CAS Registry Number

332348-12-6

Drug Class

Antirheumatic Agents