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secukinumab (Subcutaneous route)

sek-ue-KIN-ue-mab

Commonly used brand name(s)

In the U.S.

  • Cosentyx

Available Dosage Forms:

  • Powder for Solution
  • Solution

Therapeutic Class: Antipsoriatic

Pharmacologic Class: Monoclonal Antibody

Uses For secukinumab

Secukinumab injection is used to treat moderate-to-severe plaque psoriasis in patients who may benefit from receiving phototherapy (ultraviolet light treatment) or other treatments. It is also used to treat active psoriatic arthritis and active ankylosing spondylitis.

secukinumab is available only with your doctor's prescription.

Before Using secukinumab

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 secukinumab, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to secukinumab 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 secukinumab injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of secukinumab injection have not been performed in the geriatric population, no geriatric-specific problems have been documented to date.

Pregnancy

Pregnancy Category Explanation
All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

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.

Interactions with Medicines

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 secukinumab, 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 secukinumab 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
  • Alfentanil
  • Aminophylline
  • Artemether
  • Astemizole
  • Bacillus of Calmette and Guerin Vaccine, Live
  • Carbamazepine
  • Cisapride
  • Cyclosporine
  • Dihydroergotamine
  • Ergotamine
  • Fentanyl
  • Fosphenytoin
  • Iloperidone
  • Influenza Virus Vaccine, Live
  • Lumefantrine
  • Measles Virus Vaccine, Live
  • Mumps Virus Vaccine, Live
  • Paclitaxel
  • Phenytoin
  • Pimozide
  • Poliovirus Vaccine, Live
  • Quinidine
  • Rotavirus Vaccine, Live
  • Rubella Virus Vaccine, Live
  • Sirolimus
  • Smallpox Vaccine
  • Tacrolimus
  • Terfenadine
  • Theophylline
  • Typhoid Vaccine
  • Varicella Virus Vaccine
  • Warfarin
  • Yellow Fever Vaccine

Interactions with Food/Tobacco/Alcohol

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 secukinumab. Make sure you tell your doctor if you have any other medical problems, especially:

  • Inflammatory bowel disease (eg, Crohn disease or ulcerative colitis)—Use with caution. May make this condition worse.
  • Infection, or history of—Secukinumab is not recommended for patients with an active infection, including tuberculosis. Caution should be used if you have a chronic infection or history of a recurring infection.
  • Tuberculosis infection, inactive—Should be treated first before starting therapy with secukinumab.

Proper Use of secukinumab

A nurse or other trained health professional will give you secukinumab. secukinumab is given as a shot under your skin, usually on the upper arms, abdomen (stomach), or thighs.

secukinumab comes with a Medication Guide and patient instructions. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Secukinumab may sometimes be given at home to patients who do not need to be in the hospital or clinic. If you are using secukinumab at home, your doctor or nurse will teach you how to prepare and inject the medicine. Be sure that you understand how to use the medicine.

Secukinumab comes in 3 forms: a Sensoready® pen, a prefilled syringe (both of which may be used at home), and powder for solution (which is to be used only in the hospital or doctor's office). Your doctor will tell you which dosage form you should use.

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.

You might not use all of the medicine in each pen or prefilled syringe. Use each pen or prefilled syringe only one time. Do not save an open pen or syringe. If the medicine in the pen or syringe has changed color, or if you see particles in it, do not use it. Do not shake the medicine.

The removable cap of the Sensoready® pen or prefilled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you have a latex allergy before you start receiving secukinumab.

Dosing

The dose of secukinumab 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 secukinumab. 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:
    • For ankylosing spondylitis:
      • Adults—150 milligrams (mg) every 4 weeks. Some patients may first receive "loading" doses of 150 mg at weeks 0, 1, 2, 3, and 4 and then begin the every-4-weeks regimen.
      • Children—Use and dose must be determined by your doctor.
    • For plaque psoriasis:
      • Adults—300 milligrams (mg) injected under your skin at Weeks 0, 1, 2, 3, and 4. This is followed by 300 mg every 4 weeks. For some patients, a dose of 150 mg may suffice.
      • Children—Use and dose must be determined by your doctor.
    • For psoriatic arthritis:
      • Adults—150 milligrams (mg) injected under your skin every 4 weeks. Some patients may first receive "loading" doses of 150 mg at weeks 0, 1, 2, 3, and 4, and then begin the every-4-weeks regimen. Patients with continuing active psoriatic arthritis or those who also have moderate to severe plaque psoriasis may receive a dose of 300 mg.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

secukinumab needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

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 the original carton until you are ready to use it. secukinumab should be used within 1 hour after removal from the refrigerator.

Do not reuse syringes and needles. Put used syringes and needles in a puncture-resistant disposable container, or dispose of them as directed by your doctor.

Precautions While Using secukinumab

It is very important that your doctor check your progress at regular visits to make sure that secukinumab is working properly. Blood tests may be needed to check for unwanted effects.

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.

You will need to have a skin test for tuberculosis before you start using secukinumab. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis test or been exposed to tuberculosis.

Inflammatory bowel disease may occur while you are using secukinumab. Tell your doctor right away if you have rectal bleeding, severe abdominal or stomach pain, or severe diarrhea while using secukinumab.

secukinumab may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using secukinumab.

While you are being treated with secukinumab, and after you stop treatment with it, do not have any immunizations (vaccines) without your doctor's approval. Secukinumab may lower your body's resistance and the vaccine may not work as well or you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.

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.

secukinumab 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
  • Fever
  • headache
  • muscle aches
  • sore throat
  • stuffy or runny nose
  • unusual tiredness or weakness
Less common
  • Body aches or pain
  • chills
  • cough
  • difficulty with breathing
  • ear congestion
  • hives or welts, itching, or skin rash
  • loss of voice
  • redness of the skin
Incidence not known
  • Diarrhea
  • difficulty with swallowing
  • dizziness
  • fast heartbeat
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rectal bleeding
  • severe diarrhea
  • severe stomach pain
  • tightness in the chest
  • weight loss

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.

See also: Side effects (in more detail)

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