Sarilumab Side Effects
Medically reviewed by Drugs.com. Last updated on Dec 20, 2024.
Applies to sarilumab: subcutaneous solution.
Important warnings
This medicine can cause some serious health issues
Subcutaneous route (solution)
Risk of Serious Infections. Patients treated with sarilumab are at increased risk for developing serious infections that may lead to hospitalization or death.
Opportunistic infections have also been reported in patients receiving sarilumab.
Most patients who developed infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.Avoid use of sarilumab in patients with an active infection.Reported infections include: Active tuberculosis, which may present with pulmonary or extrapulmonary disease.
Patients should be tested for latent tuberculosis before sarilumab use and during therapy.
Treatment for latent infection should be initiated prior to sarilumab use.
Invasive fungal infections, such as candidiasis, and pneumocystis.
Patients with invasive fungal infections may present with disseminated, rather than localized, disease.
Bacterial, viral and other infections due to opportunistic pathogens.Closely monitor patients for signs and symptoms of infection during treatment with sarilumab.
If a serious infection develops, interrupt sarilumab until the infection is controlled.Consider the risks and benefits of treatment with sarilumab prior to initiating therapy in patients with chronic or recurrent infection.
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.
Serious side effects of sarilumab
Along with its needed effects, sarilumab 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 while taking sarilumab:
More common side effects
- 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 side effects
- 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 side effects
- 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
Other side effects of sarilumab
Some side effects of sarilumab 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 side effects
- 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
For healthcare professionals
Applies to sarilumab: subcutaneous solution.
General adverse events
The most frequently reported side effects included infections, upper respiratory tract infections, urinary tract infections, nasopharyngitis, neutropenia, increased ALT, injection site erythema, leukopenia, injection site pruritus, constipation, pruritic rash, myalgia, and fatigue.
The most common side effects resulting in discontinuation were neutropenia, increased ALT, infection, COVID-19, intervertebral discitis, and pneumonia.[Ref]
Dermatologic
- Common (1% to 10%): Erythema, pruritus, pruritic rash
- Uncommon (0.1% to 1%): Cellulitis[Ref]
Gastrointestinal
- Common (1% to 10%): Oral herpes, constipation, diarrhea
- Uncommon (0.1% to 1%): Diverticulitis
- Rare (0.01% to 0.1%): Gastrointestinal (GI) perforation[Ref]
Reports of GI perforation was primarily reported as complications of diverticulitis including lower GI perforation and abscess.[Ref]
Genitourinary
- Common (1% to 10%): Urinary tract infection[Ref]
Hematologic
- Very common (10% or more): Neutropenia
- Common (1% to 10%): Leukopenia, thrombocytopenia
- Uncommon (0.1% to 1%): Decreased platelet counts[Ref]
Hepatic
- Very common (10% or more): Elevated ALT (up to 43%), elevated AST (up to 30%)
- Common (1% to 10%): Transaminases increased[Ref]
Hypersensitivity
- Uncommon (0.1% to 1%): Hypersensitivity reactions[Ref]
Immunologic
- Common (1% to 10%): Serious infections
- Frequency not reported: Immunosuppression[Ref]
Local
- Common (1% to 10%): Injection site reactions, injection site erythema, injection site pruritus[Ref]
Metabolic
- Common (1% to 10%): Lipid abnormalities, hypertriglyceridemia, hypercholesterolemia[Ref]
Lipid abnormalities included elevated low-density lipoprotein, high-density lipoprotein, and triglycerides.[Ref]
Musculoskeletal
- Common (1% to 10%): Myalgia, rheumatoid arthritis
- Frequency not reported: Intervertebral discitis
Nervous system
- Common (1% to 10%): Headache
Respiratory
- Common (1% to 10%): Upper respiratory tract infection, nasopharyngitis
- Uncommon: Pneumonia
- Frequency not reported: COVID-19, bronchitis, influenza[Ref]
Oncologic
- Common (1% to 10%): Malignancies
Other
- Common (1% to 10%): Fatigue
- Frequency not reported: Herpes zoster, drug specific antibody
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References
1. (2017) "Product Information. Kevzara (sarilumab)." sanofi-aventis
2. (2023) "Product Information. Kevzara (sarilumab)." sanofi-aventis
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Further information
Sarilumab side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.