200 mg injection, solution in a prefilled pen
dupilumab
1. What Dupixent is and what it is used for
What Dupixent is
Dupixent contains the active substance dupilumab.
Dupilumab is a monoclonal antibody (a type of specialized protein ) that blocks the action of the proteins IL-4 and IL-13. Both play an important role in causing the signs and symptoms of asthma.
What Dupixent is used for
Dupixent is used to treat adults and adolescents aged 12 years and older with moderate to severe atopic dermatitis, also called atopic eczema. Dupixent is also used to treat children aged 6 to 11 years with severe atopic dermatitis (see section Children and adolescents). Dupixent can be used alone or with eczema medicines that you apply to the skin.
Dupixent is used in combination with other asthma medicines for the maintenance treatment of severe asthma in adults and adolescents (12 years and older) whose asthma is not controlled by their current asthma medicine.
How Dupixent works
Using Dupixent for atopic dermatitis ( atopic eczema ) may improve the condition of the skin and reduce itching. Dupixent has also been shown to relieve the symptoms of pain, anxiety, and depression associated with atopic dermatitis. Also, Dupixent reduces sleep disorders and provides an improved quality of life.
Dupixent helps prevent severe asthma attacks ( exacerbations ) and can improve breathing. Dupixent can also help reduce the amount of another group of medicines you need to control your asthma, called oral corticosteroids while preventing severe asthma attacks and improving breathing.
2. What you need to know before using Dupixent
Do not use Dupixent
- if you are allergic to dupilumab or any of the other ingredients of this medicine (listed in section 6).
- If you think you may be allergic, or if you are unsure, ask your doctor, pharmacist, or nurse before using Dupixent.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Dupixent.
Dupixent is not an emergency medicine and should not be used to treat a sudden asthma attack.
Allergic reactions
- In very rare cases, Dupixent may cause serious side effects, such as allergic (hypersensitivity) reactions and anaphylactic reactions, as well as angioedema. These reactions may occur from minutes to up to seven days after administration of Dupixent. You must be aware of signs of these conditions (eg difficulty breathing, swelling of the face, lips, mouth, throat, or tongue, fainting, dizziness, fainting (low blood pressure ), fever, general malaise, swollen lymph nodes, hives, itching, joint pain, redness of the skin) when you take Dupixent. Such signs are listed under “Serious side effects” in section 4.
- Stop using Dupixent and tell your doctor or seek medical help immediately if you notice any signs of an allergic reaction.
Eosinophilic conditions
- In rare cases, patients using asthma medications may develop inflammation of blood vessels or lungs due to an increase in certain white blood cells ( eosinophils).
- It is not known if this is caused by Dupixent. This usually happens but not always in people who are also taking corticosteroids that are discontinued or for which dose one is lowered.
- Tell your doctor immediately if you develop a combination of symptoms such as flu-like illness, tingling or numbness in the arms or legs, worsening of lung symptoms, and/or skin rash.
Parasite infections (in the intestinal tract)
- Dupixent may weaken your resistance to infection caused by parasites. If you already have a parasite infection, it must be treated before you can start treatment with Dupixent.
- Talk to your doctor if you have diarrhea, gas, upset stomach, fecal discharge, and dehydration, which may be signs of a parasitic infection.
- If you live in an area where these infections are common or if you travel to such an area, you should consult your doctor.
Asthma
If you have asthma and use asthma medications, do not change or stop them without discussing them with your doctor. Talk to your doctor before stopping Dupixent or if your asthma remains uncontrolled or worsens during treatment with this medicine.
Eye problems
Talk to your doctor if you experience new or worsening eye problems, including eye pain or vision changes.
Children and young people
- The pre-filled pen with Dupixent is not intended for use in children under 12 years of age. For children aged 6-11 years with atopic dermatitis, contact your doctor who will prescribe a suitable pre-filled syringe of Dupixent.
- The safety and benefits of Dupixent are not yet known in children with atopic dermatitis under 6 years of age.
- The safety and benefits of Dupixent are not yet known in children with asthma under 12 years of age.
Other medicines and Dupixent
Tell your doctor or pharmacist
- if you are taking, have recently taken, or might take any other medicines.
- if you have recently received or are about to receive a vaccination.
Other medicines for asthma
Do not stop or reduce the dose of your asthma medicine unless your doctor tells you to.
- These drugs (especially those called corticosteroids ) must be discontinued gradually
- This must be done under the direct supervision of your doctor and depending 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 using this medicine. The effect of this medicine on pregnant women is unknown, therefore Dupixent should not be used during pregnancy unless your doctor recommends it.
- If you are breast-feeding or planning to breast-feed, talk to your doctor before using this medicine. You and your doctor should decide together whether to breast-feed or use Dupixent. You should not do both.
Driving and using machines
Dupixent is unlikely to affect your ability to drive or use machines.
Dupixent contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per 200 mg dose, ie essentially ‘ sodium-free’. it is basically “sodium-free”.
3. How to use Dupixent
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
How Dupixent is given
Dupixent is given by injection under the skin ( subcutaneous injection ).
How much Dupixent you will get
Your doctor will decide which dose of Dupixent is right for you.
The recommended dose in adolescents with atopic dermatitis
The recommended dose of Dupixent for adolescents (12 to 17 years) with atopic dermatitis is based on body weight:
| Patient’s body weight | Initial dose | Followers island FOLLOWS dose s (every two weeks) |
| less than 60 kg | 400 mg (two 200 mg injections) | 200 mg |
| 60 kg or more | 600 mg (two 300 mg injections) | 300 mg |
The recommended dose in children with atopic dermatitis
The recommended dose of Dupixent for adolescents (6 to 11 years) with atopic dermatitis is based on body weight:
| Bodyweight (kg) | Initial dose | Followers island FOLLOWS does you |
| 15 kg to less than 60 kg | 300 mg (a 300 mg injection ) on day 1, followed by 300 mg on day 15 | 300 mg was f ä RDE * week, starting 4 weeks after dose day 15 |
| 60 kg or more | 600 mg (two 300 mg injections) | 300 mg every two weeks |
* Dose one can be increased to 200 mg every two weeks based on a doctor’s assessment.
The recommended dose in adults and adolescents with asthma (12 years and older)
For most patients with severe asthma, the recommended dose is one of Dupixent:
- The first dose of 400 mg (two 200 mg injections )
- Followed by 200 mg given every two weeks administered as a subcutaneous injection.
For patients with severe asthma who receive oral corticosteroids or for patients with severe asthma and concomitant moderate to severe atopic dermatitis or adults with concomitant severe chronic sinusitis with nasal polyps, the recommended dose is one of Dupixent:
- The first dose of 600 mg (two 300 mg injections )
- Followed by 300 mg every two weeks administered as a subcutaneous injection.
Injection of Dupixent
Dupixent is given by injection under the skin ( subcutaneous injection ). You and your doctor or nurse will decide together whether to inject Dupixent yourself.
Before you inject Dupixent yourself, you must have been trained by your doctor or nurse. Your healthcare provider may also give you Dupixent after being trained by a doctor or nurse.
Each pre-filled pen contains a dose of Dupixent (200 mg). Do not shake the pre-filled pen.
Read the “Instructions for use” for the pre-filled pen carefully before using Dupixent.
If you use more Dupixent then you should
If you take more Dupixent than you should or if you have been given a dose too soon, talk to your doctor, pharmacist, or nurse.
If you forget to use Dupixent
If you forget to inject a dose of Dupixent, talk to your doctor, pharmacist, or nurse.
If you stop using Dupixent
Do not stop using Dupixent without talking to your doctor first.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Dupixent can cause serious side effects, such as very rare allergic (hypersensitivity) reactions including anaphylactic reactions. Signs of an allergic reaction or anaphylactic reaction may include:
- breathing problems
- swelling of the face, lips, mouth, throat, or tongue ( angioedema )
- fainting, dizziness, fainting (low blood pressure )
- fever
- general malaise
- swollen lymph nodes
- hives
- itching
- joint pain
- rash
If you develop an allergic reaction, stop using Dupixent and talk to your doctor straight away.
Other side effects are
Very common (may affect more than 1 user in 10) for atopic dermatitis and asthma:
- injection site reactions (such as redness, swelling, and itching )
Common (may affect up to 1 in 10 people) for atopic dermatitis only:
- headache
- dryness, redness, and itching of the eyes
- itching, redness, and swelling of the eyelids
- eye infection
- cold sores (on lips and skin)
Uncommon (may affect up to 1 in 100 people):
- Inflammation of the cornea of the eye, sometimes with blurred vision ( keratitis, ulcerative keratitis )
No known frequency
The following side effects have been reported with post-marketing experience with Dupixent, however, the frequency with which they have been reported is unknown:
- joint pain ( arthralgia )
5. How to store Dupixent
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 label and carton after EXP. The expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C to 8 ° C). If required, pre-filled pens can be stored at room temperature for up to 25 ° C for a maximum of 14 days. Do not store above 25 ° C. If you need to remove the carton from the refrigerator permanently, write the date of removal from the refrigerator at the designated place on the carton, and use Dupixent within 14 days.
Store in the original package. Sensitive to light.
Do not use this medicine if the solution is cloudy, discolored, or contains 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.
6. Contents of the packaging and other information
Content declaration
- The active substance is dupilumab.
- Each pre-filled pen contains 200 mg dupilumab in 1.14 ml solution for injection ( injection ).
- The other ingredients are arginine hydrochloride, histidine, polysorbate 80 (E433), sodium acetate, acetic acid (E260), sucrose, water for injections.
What the medicine looks like and the contents of the pack
Dupixent is a clear to slightly opalescent, colorless to pale yellow solution in a pre-filled pen.
Dupixent is available as 200 mg pre-filled pens in packs containing 1, 2, 3, or 6 pre-filled pens.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Sanofi-aventis group
54, rue La Boétie
75008 Paris
France
Manufacturer
SANOFI WINTHROP INDUSTRY
1051 Boulevard Industriel,
76580 LE TRAIT,
FRANCE
Sanofi-Aventis Deutschland GmbH
Brüningstrasse 50
Industrial park Hoechst
65926 FRANKFURT AM MAIN
GERMANY
Contact the representative of the marketing authorization holder to find out more about this medicine:
Sanofi AB
Tel: +46 (0) 8 634 50 00