Secukinumab
Generic name: secukinumab
Brand name: Cosentyx
Dosage form: injection, intravenous infusion
Drug class: Interleukin inhibitors
What is secukinumab?
Secukinumab (Cosentyx) is used to treat types of plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, enthesitis-related arthritis, and non-radiographic axial spondyloarthritis, which are autoimmune conditions. Cosentyx is an immunosuppressant medicine that reduces the effects of a chemical substance in the body that can cause inflammation.
Secukinumab is from a group of medicines called interleukin (IL) inhibitors, and works by blocking the activity of a protein called IL-17A. People who have autoimmune conditions have increased levels of this protein. By blocking the protein's activity, it reduces inflammation, pain, swelling, and skin symptoms that you may have.
Secukinumab is available as a subcutaneous injection (an injection under the skin) and as an intravenous (IV) formulation.
What is secukinumab used for?
Secukinumab is FDA approved to treat:
- moderate to severe plaque psoriasis in patients 6 years and older who are candidates for systemic therapy or phototherapy
- active psoriatic arthritis (PsA) in patients 2 years of age and older
- adults with active ankylosing spondylitis
- adults with active non-radiographic axial spondyloarthritis (nr-axSpA) and objective signs of inflammation
- active enthesitis-related arthritis (ERA) in patients 4 years of age and older
This medicine may improve your psoriasis, psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis, and enthesitis-related arthritis, but it may also lower the ability of your immune system to fight infections.
Secukinumab side effects
Common secukinumab side effects may include diarrhea or cold symptoms such as stuffy nose, sneezing, and sore throat.
Serious secukinumab side effects
Get emergency medical help if you have signs of an allergic reaction to secukinumab, including hives; chest tightness, difficulty breathing; feeling like you might pass out; and swelling of your face, lips, tongue, or throat.
Call your doctor right away if you have signs of infection such as
- redness, warmth, or painful sores on your skin;
- cough, shortness of breath, cough with red or pink mucus;
- increased urination, burning when you urinate;
- sores or white patches in your mouth or throat (yeast infection or "thrush");
- new or worsening diarrhea or stomach pain; or
- fever, chills, sweating, muscle pain, weight loss.
Further doses may be delayed until your infection clears up.
This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Warnings
You may get infections more easily while using secukinumab, as it lowers your immune system's ability to fight infections. Call your doctor right away if you have signs of infection such as fever, chills, sweats, muscle aches, skin sores, stomach pain, diarrhea, burning when you urinate, weight loss, cough, shortness of breath, or a cough with red or pink mucus.
Tell your doctor if you have an active infection or have ever been diagnosed with tuberculosis or inflammatory bowel disease before using this medicine.
Before using this medicine
You should not use secukinumab if you are allergic to it or any of the inactive ingredients contained in the medicine.
Tell your doctor if you've had or been exposed to tuberculosis, or if you recently traveled. Some infections are more common in certain parts of the world, and you may have been exposed during travel.
To make sure you can safely use secukinumab, tell your doctor if you have ever had:
- an active or chronic infection;
- inflammatory bowel disease (Crohn's disease or ulcerative colitis);
- an allergy to latex (The needle cap on the Cosentyx Sensoready 150 mg/mL pen, 150 mg/mL and 75 mg/0.5 mL prefilled syringes contains latex), or
- if you currently have signs of infection such as fever, sweats, chills, muscle pain, cough, shortness of breath, cough with bloody mucus, weight loss, skin sores, stomach pain, diarrhea, or painful urination.
Make sure you are current on all vaccines before you start using this medicine. You should not have any vaccinations during your treatment with secukinumab without first talking to your doctor.
Pregnancy
Tell your doctor if you are pregnant or plan to become pregnant. It is not known if secukinumab can harm your unborn baby. You and your healthcare provider should decide if you will use this medicine.
Breastfeeding
Tell your doctor or healthcare professional if you are breastfeeding or plan to breastfeed. It is not known if secukinumab passes into your breast milk.
How should I use secukinumab?
Use secukinumab for self-administration exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Ask your doctor or pharmacist if you don't understand how to use an injection.
If you prefer to have a healthcare provider administer Cosentyx to you, it is available as a monthly, 30-minute, intravenous infusion requiring no pre-medication and no laboratory monitoring.
Subcutaneous secukinumab
Cosentyx for self-administration at home is injected under the skin (subcutaneous injection).
- Take the injection pen out of the refrigerator and let it reach room temperature for 15 to 30 minutes before use. Give the injection within 1 hour after removing the medicine from the refrigerator. Do not try to warm the medication by heating it in a microwave, placing it in hot water, or through any other method.
- Prepare an injection only when you are ready to give it. You may need to use 2 injections to get your total dose.
- The solution should be clear or light-yellow. Call your pharmacist if the liquid in your vial, pen, or syringe looks cloudy, has changed colors, or has particles in it.
- Do not shake the syringe or dosing pen.
- The injection can be given anywhere on the front of your thighs (upper leg), upper outer arms, or abdomen (stomach) except your navel and the area 2 inches (5 centimeters) around it. Do not inject into the same place two times in a row. Avoid injecting into the skin that is hard, red, bruised, swollen, tender, or affected by psoriasis.
- Throw away a prefilled syringe or injection pen after one use, even if there is still medicine left inside.
- Do not reuse a needle or syringe. Place them in a puncture-proof "sharps" container and dispose of them following state or local laws. Keep out of the reach of children and pets.
You may get infections more easily, even serious infections. You will need frequent medical tests.
See the detailed “Instructions for Use” which for information and diagrams on how to prepare and inject a dose of secukinumab and how to properly throw away (dispose of) used secukinumab Sensoready pen and prefilled syringes.
Dosing information
Your dosage of secukinumab depends on which condition you are treating, your age, weight and sometimes how well your treatment is responding to treatment. If you have a loading dose you will be given a weekly dose on weeks 0, 1, 2, 3 and 4 and then have injections every 4 weeks. If you do not have a loading dose your injections will be every 4 weeks.
Related/similar drugs
Otezla, Sotyktu, Cimzia, prednisone, naproxen, methotrexate, Humira, cyclosporine, Rinvoq, adalimumab
What other drugs will affect secukinumab?
Secukinumab may interact with other products, so tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Know the medicines you take and keep a list to show your healthcare provider and pharmacist when you start a new medicine or stop a regular medicine.
When starting or stopping this medicine for patients who are receiving a CYP450 substrate medicine, particularly those with a narrow therapeutic index, your therapeutic effect or drug concentration may be monitored, and you may need to have a dosage adjustment of the CYP450 substrate. Not all possible interactions are listed here. To check for interactions with secukinumab, click on the link below.
Storage
- Store this medicine in a refrigerator, between 36°F to 46°F (2°C to 8°C).
- Keep this medicine in the original carton until ready for use to protect from light.
- Secukinumab Sensoready pen and secukinumab 150 mg/mL secukinumab prefilled syringe may be stored at room temperature, up to 86°F (30°C), for up to 4 days.
- Write the date the Sensoready pen or 150 mg/mL prefilled syringe was removed from the refrigerator in the space provided on the carton.
- If unused and not stored above 30°C (86°F), secukinumab Sensoready pen and 150 mg/mL prefilled syringe may be returned to the refrigerator.
- Throw away secukinumab Sensoready pen or secukinumab 150 mg/mL prefilled syringe if it has been kept outside of the refrigerator and has not been used in over 4 days.
- Do not freeze this medicine.
- Do not shake this medicine.
- Throw away (dispose of) any unused secukinumab Sensoready pen or prefilled syringes.
- Keep all medicines out of the reach of children.
What are the ingredients in secukinumab?
Active ingredient: secukinumab.
Inactive ingredients:
Cosentyx Sensoready pen and prefilled syringe: L-histidine/histidine hydrochloride monohydrate, L-methionine, polysorbate 80, trehalose dihydrate, and sterile water for injection.
Cosentyx Vial: L-histidine/histidine hydrochloride monohydrate, polysorbate 80, and sucrose.
Manufacturer:
Cosentyx is manufactured by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936.
Secukinumab Biosimilars
Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.
Reference products
These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for secukinumab.
Cosentyx (secukinumab) - Novartis Pharmaceuticals Corporation
Formulation type | Strength |
---|---|
Autoinjector | 150 mg/mL |
Autoinjector | 300 mg/2 mL |
Pre-Filled Syringe | 150 mg/mL |
Pre-Filled Syringe | 300 mg/2 mL Discontinued |
Pre-Filled Syringe | 75 mg/0.5 mL |
Single-Dose Vial | 125 mg/5 mL |
Single-Dose Vial | 150 mg Discontinued |
View Cosentyx information in detail.
Popular FAQ
Cosentyx vs Humira: How do they compare?
Both Cosentyx and Humira are available as subcutaneous injections (which means given under the skin) and may be used to treat certain inflammatory conditions such as plaque psoriasis, psoriatic arthritis, hidradenitis suppurativa, and ankylosing spondylitis. Cosentyx is also available as an IV injection that can be administered by a healthcare provider. After an initial loading dose, Humira is given every two weeks and Cosentyx every four weeks. Continue reading
Is Cosentyx a biologic / immunosuppressant?
Yes, Cosentyx is a biologic and immunosuppressant medicine used to treat plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and hidradenitis suppurativa, among other uses. Cosentyx may improve these medical conditions but can also lower your ability to fight infections because it is an immunosuppressant. Continue reading
Does Cosentyx have a black box warning?
No, Cosentyx does not contain a Boxed Warning, also commonly called a “Black Box Warning”. A Boxed Warning is the most serious safety drug warning issued by the FDA. Continue reading
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References
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