Dupixent 200 mg Solution

DUPIXENT contains the active substance dupilumab. Dupilumab is a monoclonal antibody (a type of specialised protein) that blocks the action of proteins called IL - 4 and IL - 13. Both play a major role in causing the signs and symptoms of atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP) and prurigo nodularis (PN).

DUPIXENT is used to treat adults, adolescents and children (6 months of age and older) with moderate - to - severe atopic dermatitis (also known as eczema, a type of inflammation of your skin resulting in itchy, red, swollen and cracked skin) whose disease is not adequately controlled with corticosteroid therapies applied as creams or ointments; or when those therapies are not advisable. DUPIXENT can be used with or without other topical corticosteroid therapies (therapies applied as creams or ointments).

DUPIXENT is also used with other asthma medicines for the maintenance treatment of moderate - to - severe asthma in adults, adolescents and children (6 years of age and older).

DUPIXENT is also used with other medicines for the maintenance treatment of severe chronic rhinosinusitis with nasal polyposis (CRSwNP) in adults whose disease is not controlled with their current CRSwNP medicines. DUPIXENT can also reduce the need for surgery and the need for systemic corticosteroid use.

DUPIXENT is also used to treat adults with prurigo nodularis (PN) whose disease is not adequately controlled with prescription therapies applied as creams or ointments; or when those therapies are not advisable. DUPIXENT can be used with or without other topical corticosteroid therapies (therapies applied as creams or ointments).

Do not use DUPIXENT

• If you are allergic (hypersensitive) to dupilumab or any of the other ingredients of DUPIXENT (see section 6).

Warnings and precautions

DUPIXENT is not a rescue medicine and should not be used to treat a sudden asthma attack.

Talk to your doctor or health care provider before you use DUPIXENT:

Allergic reactions

• DUPIXENT can cause serious side effects, including allergic (hypersensitivity) reactions, anaphylactic reactions and angioedema. You must look out for signs of these conditions (i.e. breathing problems, swelling of the face, lips, mouth, throat or tongue, fainting, dizziness, feeling lightheaded [low blood pressure], fever, general ill feeling, swollen lymph nodes, hives, itching, joint pain, skin rash) while you are using DUPIXENT. Such signs are listed under “Serious side effects” in section 4.
• Stop using DUPIXENT and tell your doctor or get medical help immediately if you notice any signs of an allergic reaction.

Eosinophilic conditions

• Patients taking an asthma medicine may develop inflammation of blood vessels or lungs due to an increase of certain white blood cells (eosinophilia).
• It is not known whether this is caused by DUPIXENT. This usually, but not always, happens in people who also take a steroid medicine which is being stopped or for which the dose is being lowered.
• Tell your doctor immediately if you develop a combination of symptoms such as a flu - like illness, pins and needles or numbness of arms or legs, worsening of pulmonary symptoms and/or rash.

Parasitic (intestinal parasites) infection

• DUPIXENT may weaken your resistance to infections caused by parasites. If you already have a parasitic infection, it should be treated before you start treatment with DUPIXENT.
• Check with your doctor if you feel bloated, have diarrhoea, an upset stomach, greasy stools and dehydration, which could be a sign of a parasitic infection.
• If you live in a region where these infections are common or if you are travelling to such a region check with your doctor.

Asthma

If you have asthma and are taking asthma medicines, do not change or stop your asthma medicine without talking to your doctor. Talk to your doctor before you stop DUPIXENT or if your asthma remains uncontrolled or worsens during treatment with DUPIXENT.

Eye problems

Talk to your doctor if you have any new or worsening eye problems, including eye pain or changes in vision.

Children and adolescents

• In children 6 months to less than 12 years of age, DUPIXENT should be given by a caregiver.
• In children 12 years of age and older, it is recommended that DUPIXENT be administered by or under supervision of an adult.
• The safety and benefits of DUPIXENT are not yet known in children with atopic dermatitis below the age of 6 months.
• The safety and benefits of DUPIXENT are not yet known in children with asthma below the age of 6 years.
• CRSwNP does not normally occur in children. The safety and benefits of DUPIXENT are not yet known in children with CRSwNP below the age of 18 years.
• The safety and benefits of DUPIXENT are not known in children with PN below the age of 18 years.

Other medicines and DUPIXENT

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) Please consult your doctor, pharmacist or health care provider for advice if you need to take any other medicines. Tell your doctor or health care provider if you have recently had or are due to have a vaccination.

Other medicines for asthma

Do not stop or reduce your asthma medicines, unless instructed by your doctor.

• These medicines (especially ones called corticosteroids) must be stopped gradually.
• This must be done under the direct supervision of your doctor and dependent on your response to DUPIXENT.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you use DUPIXENT. The effects of this medicine in pregnant women are not known; therefore, it is preferable to avoid the use of DUPIXENT in pregnancy. Tell your doctor, pharmacist or health care provider if you become pregnant while using DUPIXENT.

Women receiving DUPIXENT are advised to not breastfeed their babies. You and your doctor should decide if you will breastfeed or use DUPIXENT. You should not do both.

If you are breastfeeding or are planning to breastfeed, talk to your doctor before you use DUPIXENT.

Driving and using machines

DUPIXENT is unlikely to influence your ability to drive and use machines.

DUPIXENT contains sodium

DUPIXENT contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially sodium free.

Always use DUPIXENT exactly as your doctor or pharmacist has instructed you. You should check with your doctor or pharmacist if you are unsure.

Do not share medicines prescribed for you with any other person.

How DUPIXENT is given

DUPIXENT is given by injection under the skin (subcutaneous injection).

How much DUPIXENT you will receive

Your doctor will decide which dose of DUPIXENT is right for you.

ATOPIC DERMATITIS

Recommended dose in adults with atopic dermatitis

The usual dose is an initial dose of 600 mg (two 300 mg injections), followed by 300 mg (one single injection) given every other week, for adult patients. Your dosage may be increased to 300 mg (one single injection) per week.

Recommended dose in children and adolescents (6 to 17 years of age) with atopic dermatitis

The recommended dose of DUPIXENT for children and adolescents (6 to 17 years of age) with atopic dermatitis is based on body weight:

• Body weight Initial dose Subsequent doses
• 15 to less than 30 kg 600 mg (two 300 mg injections) 300 mg every 4 weeks
• 30 to less than 60 kg 400 mg (two 200 mg injections) 200 mg every other week
• 60 kg or more 600 mg (two 300 mg injections) 300 mg every other week

Recommended dose in children (6 months to 5 years of age) with atopic dermatitis

The recommended dose of DUPIXENT for children 6 months to 5 years of age with atopic dermatitis is based on body weight:

• Body weight Initial dose Subsequent doses
• 5 to less than 15 kg 200 mg (one 200 mg injection) 200 mg every 4 weeks
• 15 to less than 30 kg 300 mg (one 300 mg injection) 300 mg every 4 weeks

ASTHMA

Recommended dose in adults and adolescents (12 years of age and older) with asthma

For adults and adolescents (12 years of age and older) with moderate - to - severe asthma, the recommended dose of DUPIXENT is:

• An initial dose of 400 mg (two 200 mg injections) followed by 200 mg given every other week administered as a subcutaneous injection. Your doctor may decide to increase the dose to 300 mg every other week based on your condition.
• For patients with oral corticosteroid - dependent asthma or with co - morbid moderate - to - severe atopic dermatitis or adults with co - morbid severe chronic rhinosinusitis with nasal polyposis, an initial dose of 600 mg (two 300 mg injections) followed by 300 mg administered every other week as a subcutaneous injection.

Recommended dose in children (6 to 11 years of age) with asthma

The recommended dose of DUPIXENT for children (6 to 11 years of age) with asthma is based on body weight:

• Body weight Initial and subsequent doses
• 15 to less than 30 kg 300 mg every 4 weeks
• 30 to less than 60 kg 200 mg every other week or 300 mg every 4 weeks
• 60 kg or more 200 mg every other week

For patients 6 to 11 years old with asthma and co - morbid moderate - to - severe atopic dermatitis, your doctor will decide which dose of DUPIXENT is right for you.

CHRONIC RHINOSINUSITIS WITH NASAL POLYPOSIS

Recommended dose in adults with chronic rhinosinusitis with nasal polyposis (CRSwNP)

In CRSwNP, the recommended first dose of DUPIXENT is an initial dose of 300 mg, followed by 300 mg given every two weeks by subcutaneous injection.

PRURIGO NODULARIS

Recommended dose in adults with prurigo nodularis (PN)

For patients with prurigo nodularis, the recommended dose of DUPIXENT is an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every other week by subcutaneous injection.

DUPIXENT is given as an injection under your skin (subcutaneous injection). You and your doctor or nurse should decide if you should inject DUPIXENT yourself. Before injecting DUPIXENT yourself you must have been properly trained by your doctor or nurse. Your DUPIXENT injection may also be given by a caregiver after proper training by a doctor or nurse.

Each pre - filled syringe contains one dose of DUPIXENT 200 mg or DUPIXENT 300 mg. Do not shake the pre - filled syringe.

Read the INSTRUCTIONS FOR USE for the DUPIXENT 200 mg or DUPIXENT 300 mg pre - filled syringes before using.

The DUPIXENT 200 mg pre - filled syringe with a needle shield should be allowed to reach room temperature by waiting for 30 minutes before injecting. The DUPIXENT 300 mg pre - filled syringe with a needle shield or DUPIXENT 300 mg pre - filled syringe should be allowed to reach room temperature by waiting for 45 minutes before injecting.

DUPIXENT can be injected into the thigh or abdomen, except for the 5 cm around the navel. If somebody else administers the injection, the upper arm can also be used. It is recommended to rotate the injection site with each injection.

DUPIXENT should not be injected into skin that is tender, damaged or has bruises or scars.

Always check the label of your syringe before each injection to make sure you have the correct medicine.

If you use more DUPIXENT than you should

Contact your doctor if you inject more DUPIXENT than you should, or the dose has been given too early. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you missed a dose of DUPIXENT

If your dose schedule is every week and you miss a dose of DUPIXENT:

• Wait until the next scheduled dose to give your DUPIXENT injection.

If your dose schedule is every other week and you miss a dose of DUPIXENT:

• Give the DUPIXENT injection within 7 days from the missed dose, then continue with your original schedule.
• If the missed dose is not given within 7 days, wait until the next scheduled dose to give your DUPIXENT injection.

If your dose schedule is every 4 weeks and you miss a dose of DUPIXENT:

• Give the DUPIXENT injection within 7 days from the missed dose, then continue with your original schedule.
• If the missed dose is not given within 7 days, start a new every 4 week dose schedule from the time you remember to take your DUPIXENT injection.

Effects when treatment with DUPIXENT is stopped

It is important that you do not stop using DUPIXENT without talking to your doctor or pharmacist first.

DUPIXENT can have side effects. Not all side effects reported for DUPIXENT are included in this leaflet. Should your general health worsen or if you experience any untoward effects while you are receiving DUPIXENT, please consult your doctor, pharmacist or other healthcare provider for advice.

DUPIXENT can cause serious side effects, including generalised allergic (hypersensitivity) reactions. If any of the following happens, stop using DUPIXENT and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of your hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing
• rash or itching
• fainting.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to DUPIXENT. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following:

Frequent side effects:

• injection site reactions (redness, swelling, itching)
• eye infection
• eye redness and itching
• eyelid itching, redness and swelling
• eye dryness
• cold sores (e.g. on lips and skin)
• pinworms (enterobiasis) (in children 6 to 11 years old with asthma).

Frequency of side effect not known:

• swelling of the face, lips, mouth, throat or tongue (angioedema)
• inflammation of the eye surface, sometimes with blurred vision (keratitis)
• ulcers on the outer clear layer of the eye, sometimes with blurred vision (ulcerative keratitis)
• joint pain (arthralgia)
• facial rash or redness.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist. You can also report side effects to:

• The Pharmacovigilance Unit at Sanofi: [email protected] (email), https://ae.reporting.sanofi/ (web portal) or +27 11 256 3700 (tel), or
• SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8

By reporting side effects, you can help provide more information on the safety of DUPIXENT.

Store all medicines out of reach of children. Store refrigerated at 2 °C to 8 °C in the original carton to protect from light. If necessary, pre - filled syringes may be kept at room temperature up to 25 °C for a maximum of 14 days. Do not store above 25 °C. After removal from the refrigerator, the product must be used within 14 days or discarded.

If you need to permanently remove the carton from the refrigerator, write down the date of removal in the space provided on the outer carton, and use DUPIXENT within 14 days. Do not freeze. Do not expose to heat. Do not shake. Do not use after the expiry date stated on the label and carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets). Any waste material should be disposed of in accordance with local requirements.