Pronunciation:

a-BAT-a-sept

Brand Names:

• Orencia

Dosage Forms:

• Solution
• Powder for Solution

Classifications:

Therapeutic—

Antirheumatic

Uses of This Medicine:

Abatacept injection is used alone or together with other medicines to treat moderate to severe active rheumatoid arthritis. Abatacept helps keep joint damage from getting worse after other medicines have been used and did not work well.

Abatacept injection is also used alone or together with methotrexate to treat moderate to severe active polyarticular juvenile idiopathic arthritis (pJIA).

Abatacept injection is also used alone or together with other medicines to treat active psoriatic arthritis (PsA), which is a type of arthritis that causes pain and swelling in the joints along with patches of scaly skin on some areas of the body.

Abatacept injection is also used together with other medicines (eg, calcineurin inhibitor, methotrexate) to prevent acute graft-versus-host disease (aGVHD) in patients who will undergo hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated donor.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

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.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of abatacept injection in children 2 years of age and older to treat pJIA, to treat PsA, and to prevent aGVHD. However, safety and efficacy have not been established in children younger than 2 years of age.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of abatacept injection in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults and are more likely to have cancer and serious infections, which may require caution in patients receiving abatacept injection.

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.

Other 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 taking 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.

• Adalimumab
• Alefacept
• Anakinra
• Anifrolumab-fnia
• Baricitinib
• Brodalumab
• Certolizumab Pegol
• Etanercept
• Fedratinib
• Golimumab
• Guselkumab
• Infliximab
• Ixekizumab
• Natalizumab
• Risankizumab
• Rituximab
• Ruxolitinib
• Sarilumab
• Secukinumab
• Tildrakizumab
• Tocilizumab
• Tofacitinib
• Upadacitinib
• Ustekinumab
• Vedolizumab

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adenovirus Vaccine Type 4, Live
• Adenovirus Vaccine Type 7, Live
• Bacillus of Calmette and Guerin Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Influenza Virus Vaccine, Live
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Poliovirus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Vaccine
• Typhoid Vaccine, Live
• Varicella Virus Vaccine, Live
• Yellow Fever Vaccine
• Zoster Vaccine, Live

Other interactions—

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 or
• Chronic obstructive pulmonary disease (COPD) or
• Virus infection (eg, Epstein-Barr virus, cytomegalovirus), history of—Use with caution. May make these conditions worse.

• Infections (eg, hepatitis B, bacteria, virus, fungus), active or history of or
• Tuberculosis, active or history of—Patients with these conditions may have an increased chance of side effects.

Proper Use of This Medicine:

A nurse or other trained health professional will give you or your child this medicine. This medicine is given as a shot under your skin or into a vein.

For the treatment of rheumatoid arthritis, psoriatic arthritis, and polyarticular juvenile idiopathic arthritis: If this medicine is given through a vein in your arm, it must be injected by your doctor slowly and your IV tube will need to stay in place for 30 minutes. You will receive this medicine again at 2 weeks and 4 weeks after your first dose and then every 4 weeks after.

For the prevention of acute graft-versus-host disease (aGVHD): This medicine is given through a vein in your arm. It must be injected by your doctor slowly and your IV tube will need to stay in place for 60 minutes on the day before you receive transplant (Day -1). You will receive this medicine again at Days 5, 14, and 28 after the transplant.

Abatacept may be also given as a shot under your skin. It may sometimes be given at home to patients who do not need to be in the hospital. If you or your child are using this medicine at home, your doctor or nurse will teach you how to prepare and inject the medicine. Be sure that you understand exactly how to use the medicine.

This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

If you use this medicine at home, you will be shown the body areas where this shot can be given. Use a different body area each time you give yourself or your child a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems.

This medicine is available in 3 forms: a vial (glass container), a prefilled syringe, or a ClickJect™ autoinjector. The prefilled syringe and ClickJect™ autoinjector are the dosage forms you can use at home.

Check the liquid in the prefilled syringe or ClickJect™ autoinjector. It should be clear and colorless or slightly yellow. Do not use it if it is cloudy, discolored, or if you see particles in it. Do not use the prefilled syringe or ClickJect™ autoinjector if it looks cracked or broken.

Allow 30 minutes for the syringe to warm up to room temperature. Do not warm this medicine in any other way.

Do not remove the needle cover on the prefilled syringe or the autoinjector cap while allowing the medicine to reach room temperature. Remove only if ready to use.

Check that the amount of liquid in the prefilled syringe falls at or just above the fill line. If the syringe does not have the right amount of liquid, do not use it.

Do not inject into skin areas that are red, bruised, tender, scaly, or hard, or have scars or stretch marks.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form (prefilled syringe or autoinjector):
  • For polyarticular juvenile idiopathic arthritis:
    • Children 2 years of age and older—Dose is based on body weight and must be determined by your doctor.
      • Weighing 50 kilograms (kg) or more—125 milligrams (mg) injected under your skin once a week.
      • Weighing 25 kg to less than 50 kg—87.5 mg injected under your skin once a week.
      • Weighing 10 kg to less than 25 kg—50 mg injected under your skin once a week.
    • Children younger than 2 years of age—Use and dose must be determined by your doctor.
  • For psoriatic arthritis:
    • Adults—125 milligrams (mg) injected under your skin once a week.
    • Children 2 years of age and older—Dose is based on body weight and must be determined by your doctor.
      • Weighing 50 kilograms (kg) or more—125 milligrams (mg) injected under your skin once a week.
      • Weighing 25 kg to less than 50 kg—87.5 mg injected under your skin once a week.
      • Weighing 10 kg to less than 25 kg—50 mg injected under your skin once a week.
    • Children younger than 2 years of age—Use and dose must be determined by your doctor.
  • For rheumatoid arthritis:
    • Adults—125 milligrams (mg) injected under your skin once a week. Some patients may need to have an intravenous loading dose, followed by the first 125 mg injected under your skin within a day of the intravenous injection.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Storage—

Store in the refrigerator. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Throw away used needles in a hard, closed container where the needles cannot poke through. Keep this container away from children and pets.

Precautions While Using This Medicine:

It is very important that your doctor check the progress of you or your child at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Your body's ability to fight infection may be reduced while you are being treated with abatacept (eg, pneumonia, sepsis). Check with your doctor right away if you or your child has fever, chills, cough or hoarseness, flu-like symptoms, lower back or side pain, painful or difficult urination, or unusual tiredness or weakness.

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema. These can be life-threatening and require immediate medical attention. Check with your doctor right away if you or your child has a rash, itching, large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, trouble with breathing, lightheadedness or fainting, or chest pain after you receive the medicine.

You or your child will need to have a skin test for tuberculosis before you start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis skin test.

This medicine may increase your risk for cancer, including skin cancer. Check with your doctor right away if your skin have persistent non-healing sore, reddish patch or irritated area, shiny bump, pink growth, or white, yellow or waxy scar-like area.

While you are being treated with abatacept injection or within 3 months after using it, do not have any immunizations (vaccines) without your doctor's approval. Your child's vaccines need to be current before he or she begins receiving abatacept injection. Be sure to ask your child's doctor if you have any questions about this.

This medicine contains maltose (a type of sugar) which may affect blood sugar levels. If you or your child have diabetes and you notice a change in the results of your blood sugar tests or if you have any questions, check with your doctor. Your doctor may need you to use a different test for your blood sugar levels.

Do not take other medicines for arthritis unless you talked to your doctor. This includes adalimumab (Humira®), anakinra (Kineret®), certolizumab (Cimzia®), etanercept (Enbrel®), golimumab (Simponi®), infliximab (Remicade®), rituximab (Rituxan®), or tocilizumab (Actemra®). Using any of these together with this medicine may increase your chance of having serious side effects.

Side Effects of This Medicine:

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

Agitation

back pain

bladder pain

bloody or cloudy urine

body aches or pain

chest pain or tightness

chills

coma

confusion

cough

cough producing mucus

decreased urine output

difficult, burning, or painful urination

difficult or labored breathing

dizziness

ear congestion

fever

frequent urge to urinate

headache

hostility

irritability

lethargy

loss of voice

lower back or side pain

muscle twitching

nausea or vomiting

noisy breathing

pain or tenderness around the eyes and cheekbones

rapid weight gain

seizures

sneezing

sore throat

stuffy or runny nose

trouble breathing

unusual tiredness or weakness

Less common

Blurred vision

burning or stinging of the skin

nervousness

painful cold sores or blisters on the lips, nose, eyes, or genitals

pounding in the ears

skin rash

slow or fast heartbeat

Rare

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

stomach pain or tenderness

sweating

swelling of the face, throat, or tongue

Incidence not known

Redness, soreness, or itching of the skin

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

sores, welts, blisters

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

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

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.