Rilonacept (Subcutaneous route)
- Powder for Solution
Uses of This Medicine:
Rilonacept 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, such as rash, joint pain, fever, and tiredness .
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 have not been performed on the relationship of age to the effects of rilonacept in children below 12 years of age. Safety and efficacy have not been established .
Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of rilonacept in the elderly. However, specific side effects may be especially likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of rilonacept .
|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 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.
- 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:
- Asthma or
- Diabetes or
- Immune system problems Patients with these conditions will have an increased risk of infection .
- Serious infections (e.g., HIV, hepatitis B or C, tuberculosis) Rilonacept may decrease the body's ability to fight infection .
Proper Use of This Medicine:
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 .
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:
- 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 two different sites. Your dose will be adjusted to 160 mg once a week, given as a single, 2 mL injection.
- Children and teenagers 12 to 17 years of age At first, 4.4 milligrams (mg) per kilogram (kg) of body weight up to 320 mg given as one or two, 2-milliliter (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 below 12 years of age Use and dose must be determined by your doctor .
- For cryopyrin-associated periodic syndromes:
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.
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 While Using This Medicine:
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 (e.g., increased amount of cholesterol or fats in the blood) .
Your body's ability to fight infection may be reduced while you are being treated with rilonacept. It is very important that you call your doctor at the first signs of any infection (such as fever or chills; cough or 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 .
Rilonacept 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 with 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 .
Side Effects of This Medicine:
- 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
- difficulty in breathing
- ear congestion
- loss of voice
- nasal congestion
- runny nose
- sore throat
- unusual tiredness or weakness
- Incidence not known
- Bloody or black, tarry stools
- cough producing mucus
- lower back or side pain
- pain or tenderness around eyes and cheekbones
- painful or difficult urination
- severe stomach pain
- shortness of breath or troubled breathing
- tightness of chest or wheezing
- vomiting of blood or material that looks like coffee grounds
- More common
- Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- Less common
- Stomach discomfort
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:
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: 9/15/2016