Description
Rilonacept injection is used to treat cryopyrin-associated periodic syndromes (CAPS), including familial cold autoinflammatory syndrome (FCAS) and Muckle-Wells syndrome (MWS). Rilonacept can help lessen the signs and symptoms of CAPS, including rash, joint pain, fever, and tiredness. It is also used to treat recurrent pericarditis (RP) and reduce the risk of recurrence.
Rilonacept injection is also used to maintain control of symptoms of deficiency of interleukin-1 receptor antagonist (DIRA).
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Powder for Solution
Before Using
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.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of rilonacept to treat CAPS or RP in children younger than 12 years of age and to maintain control of symptoms of DIRA in children weighing less than 10 kilograms (kg). Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of rilonacept in the elderly.
Breastfeeding
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.
Drug Interactions
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
- Adenovirus Vaccine Type 4, Live
- Adenovirus Vaccine Type 7, Live
- Anakinra
- Bacillus of Calmette and Guerin Vaccine, Live
- Dengue Tetravalent Vaccine, Live
- Etanercept
- Infliximab
- Influenza Virus Vaccine, Live
- Measles Virus Vaccine, Live
- Mumps Virus Vaccine, Live
- Poliovirus Vaccine, Live
- Rotavirus Vaccine, Live
- Rubella Virus Vaccine, Live
- Smallpox Monkeypox 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:
- Asthma or
- Diabetes or
- Infection (eg, hepatitis B, hepatitis C, HIV or AIDS), active or history of or
- Weak immune system—Use with caution. May make these conditions worse.
- Infection, active or chronic—Should not be used in patients with these conditions.
- Tuberculosis, latent—May increase risk of this condition to become active again.
Proper Use
This medicine is given as a shot under your skin. Rilonacept may sometimes be given at home to patients who do not need to be in the hospital. If you are using this medicine at home, your doctor will teach you how to prepare and inject the medicine. Be sure that you understand exactly how the medicine is prepared and injected.
This medicine comes with a patient instructions. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.
Use a new needle and syringe each time you inject your medicine.
You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections. Do not inject into skin areas that are bruised, red, tender, or hard.
This powder medicine must be mixed with the liquid provided in your dose kit. Mix the medicine only when you are ready to use it. Do not use if it is cloudy or has specks floating in it.
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 (vial):
- For cryopyrin-associated periodic syndromes and recurrent pericarditis:
- Adults—At first, 320 milligrams (mg) given as two, 2-milliliter (mL) doses of 160 mg injected under the skin on the same day at 2 different sites. Your dose will be adjusted to 160 mg once a week, given as a single, 2 mL injection.
- Children 12 to 17 years of age—Dose is based on body weight and must be determined by your doctor. At first, 4.4 milligrams (mg) per kilogram (kg) of body weight up to 320 mg given as one or two, 2 mL doses injected under the skin. Your dose will be adjusted to 2.2 mg per kg of body weight up to 160 mg once a week, given as a single, 2 mL injection.
- Children younger than 12 years of age—Use and dose must be determined by your doctor.
- For deficiency of IL-1 receptor antagonist:
- Adults—320 milligrams (mg) given as two, 2-milliliter (mL) doses of 160 mg injected under the skin on the same day at 2 different sites once a week.
- Children weighing 10 kilograms (kg) or more—Dose is based on body weight and must be determined by your doctor. At first, 4.4 milligrams (mg) per kilogram (kg) of body weight up to 320 mg given as one or two, 2 mL doses injected under the skin on the same day at 2 different sites once a week.
- Children weighing less than 10 kg—Use and dose must be determined by your doctor.
- For cryopyrin-associated periodic syndromes and recurrent pericarditis:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
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.
Once the powder medicine has been mixed with the liquid, this mixture may be stored at room temperature, away from direct light. You must use this mixture within 3 hours. Throw away any leftover mixture.
Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.
Precautions
It is important that your doctor check your progress 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 an infection may be reduced while you are being treated with rilonacept. It is very important that you call your doctor right away if you or your child have a fever, chills, cough, hoarseness, lower back or side pain, or painful or difficult urination.
While you are being treated with rilonacept, do not have any immunizations (vaccinations) without your doctor's approval. Rilonacept may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. Tell your doctor about any vaccinations you have received in the past. Ask your doctor whether you should receive any vaccinations, including pneumonia and flu shots, before receiving rilonacept.
You 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 test.
Using this medicine may increase your risk of certain types of cancer. Talk with your doctor about this risk.
This medicine may cause a serious allergic reaction. Check with your doctor right away if you have a rash, itching, swelling of the face, tongue, and throat, trouble breathing, or chest pain after you get the injection.
Do not take adalimumab (Humira®), anakinra (Kineret®), etanercept (Enbrel®), or infliximab (Remicade®) while you are being treated with this medicine, unless your doctor says it is okay
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
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 immediately if any of the following side effects occur:
More common
- Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at site
- body aches or pain
- chills
- cough
- difficulty in breathing
- ear congestion
- fever
- headache
- loss of voice
- runny or stuffy nose
- sneezing
- sore throat
- unusual tiredness or weakness
Less common
- Bladder pain
- bloody or cloudy urine
- diarrhea
- difficult, burning, or painful urination
- frequent urge to urinate
- lower back or side pain
- stomach discomfort or pain
Incidence not known
- Bloody or black, tarry stools
- constipation
- cough producing mucus
- lower back or side pain
- pain or tenderness around eyes and cheekbones
- painful or difficult urination
- severe stomach pain
- tenderness
- tightness of chest
- trouble breathing
- vomiting of blood or material that looks like coffee grounds
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
- Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
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.
DRG-20071855
