Abatacept (Intravenous route, subcutaneous route)
- Powder for Solution
Uses of This Medicine:
Abatacept injection is used alone or together with other medicines to reduce the signs and symptoms of moderate to severe 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 in children 6 years of age and older for moderate to severe juvenile idiopathic arthritis (JIA).
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:
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.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of abatacept injection in children with JIA. However, safety and efficacy have not been established in children younger than 6 years of age.
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 likely to have cancer and serious infections, which may require caution in patients receiving abatacept injection.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
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.
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.
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
- 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
- Varicella Virus Vaccine
- Yellow Fever Vaccine
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) 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.
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.
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 the instructions carefully. Ask your doctor 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 ClickJect™ autoinjector. The prefilled syringe and ClickJect™ autoinjector are the dosage forms you can use at home.
If the medicine in the prefilled syringe or ClickJect™ autoinjector has changed color, or if you see particles in it, do not use it.
Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.
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:
- For moderate to severe 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 intravenous injection.
- Children 6 to 17 years of age Dose is based on body weight and must be determined by your doctor.
- Children younger than 6 years of age Use and dose must be determined by your doctor.
- For moderate to severe rheumatoid arthritis:
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.
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.
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. Check with your doctor right away if you or your child has any of the following symptoms while using this medicine: 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. Anaphylaxis can be life-threatening and requires immediate medical attention. Check with your doctor right away if you or your child has a rash, itching, swelling of the face, tongue, and throat, 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.
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 talk to your doctor. This includes adalimumab (Humira®), anakinra (Kineret®), etanercept (Enbrel®), infliximab (Remicade®), or rituximab (Rituxan®). Using any of these together with this medicine may increase your chance of having serious side effects.
Side Effects of This Medicine:
- More common
- Back pain
- bladder pain
- bloody or cloudy urine
- body aches or pain
- cough producing mucus
- difficult or labored breathing
- difficult, burning, or painful urination
- ear congestion
- frequent urge to urinate
- loss of voice
- lower back or side pain
- nausea or vomiting
- noisy breathing
- pain or tenderness around the eyes and cheekbones
- sore throat
- stuffy or runny nose
- tightness of the chest
- troubled breathing
- unusual tiredness or weakness
- Less common
- Blurred vision
- burning or stinging of the skin
- chest pain
- painful cold sores or blisters on the lips, nose, eyes, or genitals
- pounding in the ears
- skin rash
- slow or fast heartbeat
- Abdominal or stomach pain or tenderness
- difficulty with swallowing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- hives or welts
- itching, pain, redness, swelling, tenderness, or warmth on the skin
- swelling of the face, throat, or tongue
- More common
- Acid or sour stomach
- 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
- stomach discomfort or upset
- Less common
- pain in the arms or legs
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:
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:
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.
Last Updated: 10/12/2016