Description
Sarilumab injection is used alone or together with other medicines to treat symptoms of moderate to severe rheumatoid arthritis who have been treated with other medicines (eg, methotrexate) that did not work well or could not be tolerated. This medicine is also used to treat polymyalgia rheumatica in patients who have been treated with other medicines (eg, corticosteroids) that did not work well or could not be tolerated.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- 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 sarilumab injection in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sarilumab injection in the elderly. However, elderly patients are more likely to have serious infections, which may require caution in patients receiving sarilumab injection.
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.
- Abatacept
- Adenovirus Vaccine Type 4, Live
- Adenovirus Vaccine Type 7, Live
- Anifrolumab-fnia
- Bacillus of Calmette and Guerin Vaccine, Live
- Baricitinib
- Cholera Vaccine, Live
- Dengue Tetravalent Vaccine, Live
- Infliximab
- 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 history of or
- Hyperlipidemia (high fats in the blood) or
- Liver disease or
- Neutropenia (low level of white blood cells) or
- Stomach or bowel disease (eg, diverticulitis, ulcer) or
- Thrombocytopenia (low number of platelets in the blood) or
- Weak immune system (eg, HIV, cancer, steroid use)—Use with caution. May make these conditions worse.
- Herpes zoster, history of or
- Tuberculosis, history of—Use with caution. May cause infections to come back (reactivate).
- Infections (eg, hepatitis B, bacteria, virus, fungus), active or recurring or
- Liver disease, active—Should not be used in patients with these conditions.
- Tuberculosis, active—Should be treated first before receiving this medicine.
Proper Use
This medicine is given as a shot under your skin. Sarilumab 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 this 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.
This medicine is available in 2 forms: You may use a prefilled syringe or aprefilled pen.
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 a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems.
Allow the medicine to warm to room temperature for 30 minutes (for the prefilled syringe) or 60 minutes (for the prefilled pen)before using it. Do not warm this medicine in any other way.
Check the liquid in the prefilled syringe or pen. It should be clear and colorless to pale yellow. Do not use this medicine if it is cloudy, discolored, or has particles in it, or if the prefilled syringe is damaged or broken. Do not shake the medicine.
Do not inject into skin areas that are red, bruised, tender, hard, or have scars or stretch marks.
Do not remove the needle cap from the prefilled syringe or pen until you are ready to use it.
You might not use all of the medicine in each prefilled syringe or pen. Use each prefilled syringe and pen only one time. Do not save an open syringe or pen.
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 pen):
- For moderate to severe rheumatoid arthritis and polymyalgia rheumatica:
- Adults—At first, 200 milligrams (mg) injected under your skin once every 2 weeks. Your doctor may adjust your dose as needed.
- Children—Use and dose must be determined by your doctor.
- For moderate to severe rheumatoid arthritis and polymyalgia rheumatica:
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
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 to protect from light. Do not use it if it has been frozen. You may also keep the medicine at room temperature for up to 14 days. Throw away unused medicine after 14 days.
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 very 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.
Sarilumab injection will lower the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers. Tell your doctor if you have any kind of infection before you start using this medicine. Also tell your doctor if you have ever had an infection that would not go away or an infection that keeps coming back.
Call your doctor right away if you start to have a cough that will not go away, weight loss, night sweats, fever, chills, or flu-like symptoms, such as a runny or stuffy nose, headache, blurred vision, or feeling generally ill. These may be signs that you have an infection.
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.
This medicine may cause serious stomach and bowel problems, especially if you have a history of ulcers or diverticulitis (inflammation of the intestines). Check with your doctor right away if you start having severe stomach cramps or pain, black, tarry stools, diarrhea, fever, or vomiting that is severe and sometimes bloody while being treated with this medicine.
This medicine may increase the amount of cholesterol and fats in your blood. If this condition occurs, your doctor may give you some medicines that can lower the amount of cholesterol and fats in the blood.
Sarilumab injection may increase your risk of having certain cancers. Talk to your doctor if you have unusual bleeding, bruising, or weakness, swollen lymph nodes in the neck, underarms, or groin, or unexplained weight loss. Also, check with your doctor right away if your skin has red, scaly patches, or raised bumps that are filled with pus.
This medicine may cause serious allergic reactions, which can be life-threatening and requires immediate medical attention. Check with your doctor right away if you have chest tightness, fast heartbeat, fever, hives, itching, skin rash, hoarseness, irritation, joint pain, stiffness, or swelling, swelling of the eyelids, face, lips, or tongue, or trouble breathing after using this medicine.
Do not have any live vaccines (immunizations) while you are being treated with sarilumab. Check with your doctor before having any vaccines.
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
- Bloody, black, or tarry stools
- chills
- cough
- fever
- lower back or side pain
- painful or difficult urination
- pale skin
- sore throat
- ulcers, sores, or white spots in the mouth
- unusual bleeding or bruising
- unusual tiredness or weakness
Less common
- Bladder pain
- bloody or cloudy urine
- body ache or pain
- difficulty breathing
- ear congestion
- frequent urge to urinate
- headache
- loss of voice
- painful cold sores or blisters on the lips
- sneezing
- stuffy or runny nose
Rare
- Chest tightness
- difficulty swallowing
- dizziness
- fast heartbeat
- heartburn
- hives, itching, skin rash
- indigestion
- nausea
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- severe stomach pain, cramping, or burning
- vomiting of material that looks like coffee grounds, severe and continuing
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
- Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
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.
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