Risankizumab-rzaa (Subcutaneous route)
ris-an-KIZ-ue-mab - rzaa
Uses of This Medicine:
Risankizumab-rzaa injection is used to treat moderate to severe plaque psoriasis in patients who may benefit from receiving phototherapy (ultraviolet light treatment) or other treatments. Plaque psoriasis is a skin disease with red patches and white scales that do not go away.
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 risankizumab-rzaa injection in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of risankizumab-rzaa injection in the elderly.
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
- Bacillus of Calmette and Guerin Vaccine, Live
- Cholera 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
- Varicella Virus Vaccine, Live
- Yellow Fever Vaccine
- Zoster Vaccine, Live
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:
- Infection, or history of—Use is not recommended for patients with an active infection, including tuberculosis. Caution should be used if you have any chronic infection or history of a recurring infection.
- Tuberculosis infection, inactive—Should be treated first before starting treatment with this medicine.
Proper Use of This Medicine:
A nurse or other trained health professional will give you this medicine. It is given as a shot under your skin, usually in the stomach, thighs, or upper arms. You or your caregiver may be trained to prepare and inject the medicine at home. Be sure that you understand how to use the medicine.
This medicine comes with a Medication Guide and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.
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 areas where the skin is tender, bruised, red, hard, thick, scaly, or in areas with scars, stretch marks, or is affected by psoriasis.
Allow the medicine to warm to room temperature for 15 to 30 minutes, without removing the syringes from the carton, before you use it. Do not warm the medicine in any other way.
Check the liquid in the prefilled syringe. It should be clear and colorless or slightly yellow and may contain small particles. Do not use the medicine if it is cloudy, discolored, or has flakes or large particles in it. Do not shake.
Use a new needle and syringe each time you inject your medicine. You might not use all of the medicine in each prefilled syringe. Use each prefilled syringe only one time. Do not save an open syringe.
Do not use the syringe if it has been dropped or damaged. Do not remove the needle cover until you are ready to use 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 injectable dosage form (solution):
- For moderate to severe plaque psoriasis:
- Adults—Two 75 milligrams (mg) (150 mg total) prefilled syringes injected under your skin at different body areas at weeks 0 and 4, and every 12 weeks after.
- Children—Use and dose must be determined by your doctor.
- For moderate to severe plaque psoriasis:
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.
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.
Store in the refrigerator. Do not freeze.
Keep the medicine in its original carton until you are ready to use it. Protect from light. Do not use the medicine if it has been frozen, even if it has been thawed.
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 very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.
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 skin test.
It is important to check with your doctor if you have any symptoms of an infection, such as fever or chills, cough or hoarseness, lower back or side pain, painful or difficult urination.
Do not have any live vaccines (immunizations) while you are being treated with risankizumab-rzaa injection. Be sure to ask your doctor if you have any questions about this.
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 of This Medicine:
- More common
- Body aches or pain
- chest pain
- difficulty in breathing
- ear congestion
- fast heartbeat
- increase in bone pain
- itching, pain, redness, swelling, tenderness, or warmth on the skin
- loss of voice
- painful blisters on the trunk of the body
- rapid, shallow breathing
- runny or stuffy nose
- sore throat
- tightness in the chest
- unusual tiredness or weakness
- Less common
- Itching of the genitals or other skin areas
- scaling of the skin
- Burning, itching, and pain in hairy areas, pus at the root of the hair
- hives or welts, itching, skin rash
- Less common
- 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
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: 9/5/2019