210 mg solution for injection in a pre-filled syringe of
brodalumab

What Kyntheum is and what it is used for

Kyntheum is a medicine that contains the active substance brodalumab. Brodalumab is a monoclonal antibody, a special type of protein that recognizes and attaches to certain proteins in your body.

Brodalumab belongs to a group of medicines called interleukin (IL) inhibitors. This drug works by blocking the activity of IL-17 proteins, which occur in elevated levels in diseases such as psoriasis.

Kyntheum is used to treat a skin disease called plaque psoriasis, which causes inflammation and scaly plaque formation in the skin. Kyntheum is used in adults with moderate to severe plaque psoriasis that affects large areas of the body.

The use of Kyntheum will improve skin healing and reduce the signs and symptoms of psoriasis, such as itching, redness, scaling, burning, tingling, cracking, flaking, and pain.

What you need to know before using Kyntheum

Do not use Kyntheum

  • if you are allergic to brodalumab or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, ask your doctor for advice before using Kyntheum
  • if you have active Crohn’s disease
  • if you have an infection that your doctor considers important (for example, active tuberculosis ).

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before using Kyntheum:

  • if you have an inflammatory disease of the gastrointestinal tract called Crohn’s disease
  • if you have an inflammation of the colon called ulcerative colitis
  • if you have ever had or still have suicidal thoughts, depression, anxiety or mood problems or have committed suicide
  • if you have an active infection or if you often get infections you
  • if you have a long-term ( chronic ) infection
  • if you have tuberculosis , have tested positive for tuberculosis or have been in close contact with someone who has tuberculosis . You may need to be treated with another medicine for tuberculosis before starting treatment with Kyntheum
  • if you have recently received or have a planned vaccination. You should not be given certain types of vaccines (so-called “live vaccines”) while you are being treated with Kyntheum.
  • if you have used Kyntheum during the last three months of pregnancy, talk to your doctor before vaccinating your baby.
  • if you are receiving any other treatment for psoriasis , such as another immunosuppressive drug or light therapy with ultraviolet (UV) light.

After starting treatment with Kyntheum, tell your doctor, pharmacist, or nurse immediately:

  • if your doctor tells you that you have developed Crohn’s disease
  • if you feel depressed, anxious or have suicidal thoughts, or have unusual mood swings
  • if you get an infection or get any signs of infection listed in section 4 “Possible side effects”
  • if you are told you have tuberculosis .

Inflammatory bowel disease ( Crohn’s disease or ulcerative colitis )

Stop using IL ‑ 17 ‑ inhibitors, such as Kyntheum, and contact a doctor or seek medical attention immediately if you experience stomach cramps and pain, diarrhea, weight loss, or blood in the stool (signs of bowel problems).

Be aware of allergic reactions

Kyntheum can cause serious side effects, including allergic reactions. Be aware of signs of these conditions while using Kyntheum.

Stop using Kyntheum and contact a doctor or seek medical attention immediately if you notice any signs of an allergic reaction. Examples of such signs are listed under “Serious side effects” in section 4.

Children and young people

Kyntheum is not recommended for children and adolescents (under 18 years of age) as it has not been studied in this age group.

Other medicines and Kyntheum

Tell a doctor or pharmacist:

  • if you are taking, have recently taken or might take any other medicines
  • if you have recently been vaccinated or if you or your infant should be vaccinated soon, see “Warnings and Precautions” in section “2. What you need to know before using Kyntheum ”.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Kyntheum has not been tested on pregnant women and it is not known if this medicine can harm your unborn baby. It is, therefore, best to avoid using Kyntheum during pregnancy. If you are a woman of childbearing potential, you should avoid becoming pregnant and must use effective contraception during treatment with Kyntheum and for at least 12 weeks after the last dose of Kyntheum.

It is not known if brodalumab is converted to breast milk. Tell your doctor if you are breastfeeding or planning to breastfeed. Your doctor will then help you decide whether to stop breastfeeding or stop using Kyntheum. Together you will consider the benefits of breastfeeding for the baby and the benefits of Kyntheum for you.

Driving and using machines

Kyntheum does not affect your ability to drive and use machines.

How to use Kyntheum

Kyntheum should be prescribed to you by a doctor who has experience in diagnosing and treating psoriasis.

Always use this medicine exactly as your doctor, pharmacist or nurse has told you. If you are not sure, talk to your doctor, pharmacist, or nurse.

How much Kyntheum is given

  • Your doctor will decide how much Kyntheum you need and for how long. The recommended dose is 210 mg (one injection ).
  • After the first dose one you need to get a weekly injection week 1 (one week after the first dose one) and week 2 (two weeks after the first dose one). Then you need to get an injection every two weeks.
  • Kyntheum is intended for long-term treatment. Your doctor will regularly check your condition to make sure the treatment is having the desired effect. Talk to your doctor if you do not feel that your signs and symptoms of psoriasis improve after receiving Kyntheum.

How Kyntheum is given

Kyntheum is given as an injection under the skin (it is called a subcutaneous injection ).

Instructions on how to give yourself the medicine

See the detailed “Instructions for Use” that come with this medicine for information on how to store, prepare and administer the injections properly at home.

  • If the doctor decides that you or a carer can give the injections at home, you or the carer should receive training in the correct way to prepare and inject Kyntheum. Do not try to inject Kyntheum until your doctor or nurse has shown you or your healthcare provider how to inject Kyntheum.
  • Do not shake the pre-filled syringe before use.
  • Kyntheum is injected into the upper part of the legs (thighs) or stomach (abdomen) by you or a caregiver. A caregiver can also give you an injection in the outside of the upper arm.
  • Do not inject into an area with bruising or where the skin is sore, red, hard or into an area of ​​skin with psoriasis .

If you use more Kyntheum than you should 

If you have used more of this medicine than you should or if you have taken a dose earlier than required, tell your doctor.

If you forget to use Kyntheum

If you forget to inject one dose of Kyntheum, inject the next dose as soon as you can. Then contact your doctor to discuss when to inject the next dose. Do not take a double dose to make up for a forgotten dose.

If you stop using Kyntheum

You should not stop using Kyntheum without talking to your doctor first. If you stop treatment, your psoriasis symptoms may return.

If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects are

Stop using Kyntheum and contact a doctor or seek medical attention immediately if you get any of the following side effects. Your doctor will decide if and when you can resume treatment.

Severe allergic reaction (may affect up to 1 in 1,000 people), signs of this may be:

  • difficult to breathe or swallow
  • low blood pressure , which can cause dizziness or fainting
  • swelling of the face, lips, tongue or throat
  • severe skin itching with red rash or raised bumps.

Any serious infection (may affect up to 1 in 100 people), signs of this may be:

  • fever, flu-like symptoms , night sweats
  • fatigue or shortness of breath, cough that does not go away
  • hot, red and painful skin, or painful rash with blisters.

Other side effects have been reported

Common side effects (may affect up to 1 in 10 people):

  • diarrhea
  • nausea
  • redness , pain, itching , bruising or bleeding at the injection site
  • fatigue
  • pain in mouth or throat
  • fungal infection ( tinea ) in the skin (including on feet and groin)
  • influenza
  • headache
  • joint pain
  • muscle aches.

Uncommon side effects (may affect up to 1 in 100 people)

  • fungal infection ( candida ) in the mouth, throat or genitals
  • watery eyes with itching , redness and swelling ( conjunctivitis )
  • low white blood cell count .

Most of these side effects are mild to moderate. If any of these side effects gets serious, talk to your doctor, pharmacist, or nurse.

Stomach cramps and pain, diarrhea, weight loss, and blood in the stool (signs of bowel problems) have also been reported with IL ‑ 17 ‑ inhibitors, such as Kyntheum.

How to store Kyntheum

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the outer carton and label on the pre-filled syringe after EXP. The expiration date is the last day of the specified month.

Store in the outer carton. Sensitive to light.

Store in a refrigerator (2 ° C-8 ° C). Do not freeze.

Kyntheum can be stored at room temperature up to 25 ° C in the outer carton for 14 days. Discard Kyntheum if not used within 14 days at room temperature.

Do not use this medicine if the solution is cloudy or discolored or contains lumps, flakes, or particles.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the pack and other information

Content declaration

  • The active substance is brodalumab. Each pre-filled syringe contains 210 mg brodalumab in 1.5 ml solution.
  • The other ingredients are proline , glutamate , polysorbate and water for injections.

What the medicine looks like and contents of the pack

Anthem is a solution for injection, which is a clear to slightly pearlescent, colorless to pale yellow liquid, without particles.

Anthem is available in packs containing 2 pre-filled syringes and in multipacks containing 6 (3 packs of 2) pre-filled syringes. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

LEO Pharma A / S

Industrial Park 55

DK-2750 Ballerup

Denmark

Manufacturer

LEO Laboratories

39 Route de Chartres

28500 Vernouillet

France

LEO Pharma A / S

Industrial Park 55

DK ‑ 2750 Ballerup

Denmark

Contact the representative of the marketing authorization holder to find out more about this medicine:

Muhammad Nadeem

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