Prospect: information for the patient

Otulfi 130mg concentrate for solution for infusion

ustekinumab

This medicine is subject to additional monitoring, which will facilitate the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section4 includes information on how to report these adverse effects.

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

This prospect has been written for the person using the medicine.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section4.

1.What is Otulfi and for what it is used

2.What you need to know before starting to use Otulfi

3.How to use Otulfi

4.Possible adverse effects

5.Storage of Otulfi

6.Contents of the package and additional information

What is Otulfi

Otulfi contains the active ingredient “ustekinumab”, a monoclonal antibody. Monoclonal antibodies are proteins that specifically identify and bind to certain proteins in the body.

Otulfi belongs to a group of medications called “immunosuppressants”. These medications act by weakening part of the immune system.

What is Otulfi used for

Otulfi is used for the treatment of the following inflammatory disease:

• moderate to severe Crohn's disease - in adults

Crohn's Disease

Crohn's disease is an inflammatory disease of the intestine. If you have Crohn's disease, you will be given other medications first. If you do not respond adequately or do not tolerate those medications, you may be given Otulfi to reduce the signs and symptoms of your disease.

No use Otulfi

• If you are allergic to ustekinumabor to any of the other ingredients of this medicine (listed in section6).
• If you have an active infectionthat your doctor thinks is important.

If you are unsure if any of the above points apply to you, talk to your doctor or pharmacist before using Otulfi.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Otulfi. Your doctor will check how you are before starting treatment. Make sure to inform your doctor about any illness you have before treatment. Also inform your doctor if you have recently been near someone who may have tuberculosis. Your doctor will examine you and do a test for tuberculosis detection before using Otulfi. If your doctor thinks you are at risk of tuberculosis, they may give you medicine to treat it.

Watch for serious side effects

Otulfi may cause serious side effects, including allergic reactions and infections. You must pay attention to certain signs of illness while using Otulfi. See the complete list of these side effects in “Serious side effects” of section4.

Tell your doctor before using Otulfi:

• If you have ever had an allergic reaction to ustekinumab.Consult your doctor if you are unsure.
• If you have ever had any type of cancer– this is because the immunosuppressants like Otulfi weaken part of the immune system. This may increase the risk of cancer.
• If you have received treatment for psoriasis with other biologics (a medicine produced from a biological source and usually administered by injection)– the risk of cancer may be higher.
• If you have or have had a recent infection or have any skin cracks (fistula).
• If you have any new lesions or changes in lesionswithin the psoriasis area or on intact skin.
• If you are taking any other treatment for psoriasis and/or psoriatic arthritis– such as any other immunosuppressant or phototherapy (when your body is treated with a type of ultraviolet (UV) light). These treatments may also weaken part of the immune system. The use of these treatments together with Otulfi has not been studied. However, it may increase the likelihood of developing immune-related diseases.
• If you are receiving or have ever received injections to treat allergies– it is unknown if Otulfi may affect these treatments.
• If you are 65years or older– you are more likely to acquire infections.

If you are unsure if you have any of these conditions, talk to your doctor or pharmacist before using Otulfi.

Some patients have experienced reactions similar to lupus during treatment with ustekinumab, including cutaneous lupus or lupus-like syndrome. Talk to your doctor immediately if you experience red, raised, and scaly skin rash, sometimes with a darker border, in sun-exposed areas or accompanied by joint pain.

Heart attacks and strokes

In a study of patients with psoriasis treated with ustekinumab, heart attacks and strokes have been observed. Your doctor will check your risk factors for heart disease and stroke regularly to ensure they are properly treated. Seek medical attention immediately if you experience chest pain, weakness, or abnormal sensation in one side of the body, facial paralysis, or abnormalities in speech or vision.

Children and adolescents

Otulfi is not recommended for use in children under 18years of age with Crohn's disease, as it has not been studied in this age group.

Using Otulfi with other medicines, vaccines

Inform your doctor or pharmacist:

• If you are using, have used recently, or may use other medicines.
• If you have been vaccinated recently or are to receive a vaccine. Certain types of vaccines (live vaccines) should not be administered while using Otulfi.
• If you received Otulfi during pregnancy, inform your baby's doctor about your treatment with Otulfi before the baby receives any vaccine, including live vaccines, such as the BCG vaccine (used to prevent tuberculosis). Live vaccines are not recommended for your baby in the first six months after birth if you received Otulfi during pregnancy, unless your baby's doctor recommends otherwise.

Pregnancy and breastfeeding

• It is preferable to avoid using Otulfi during pregnancy. The effects of Otulfi on pregnant women are unknown. If you are fertile, it is recommended that you avoid becoming pregnant and use suitable contraceptive measures while using Otulfi and for at least 15weeks after the last treatment with Otulfi.
• Inform your doctor if you are pregnant, think you may be pregnant, or intend to become pregnant.
• Ustekinumab may pass through the placenta to the fetus. If you received Otulfi during pregnancy, your baby may have a higher risk of contracting an infection.
• It is essential to inform your baby's doctors and other healthcare professionals if you received Otulfi during pregnancy before your baby receives any vaccine. Live vaccines, such as the BCG vaccine (used to prevent tuberculosis), are not recommended for your baby in the first six months after birth if you received Otulfi during pregnancy, unless your baby's doctor recommends otherwise.
• Ustekinumab may be excreted in breast milk in very small amounts. Inform your doctor if you are breastfeeding or plan to do so. You and your doctor will decide whether to breastfeed or use Otulfi. Do not do both at the same time.

Driving and operating machinery

The influence of Otulfi on the ability to drive and operate machinery is negligible or insignificant.

Otulfi contains sodium

Otulfi contains less than 1mmol of sodium (23mg) per dose; this is, essentially “sodium-free”. However, before Otulfi is administered to you, it is mixed with a solution that contains sodium. Talk to your doctor if you follow a low-sodium diet.

Otulfi should be used under the guidance and supervision of a doctor with experience in diagnosing and treating Crohn's disease.

Your doctor will administer Otulfi 130 mg concentrate for infusion via a drip in a vein in your arm (intravenous infusion) for at least one hour. Ask your doctor when they should give you the injections and about follow-up appointments.

What dose of Otulfi is administered

Your doctor will decide how much Otulfi you need to receive and the duration of treatment.

Adults 18 years of age and older

• Your doctor will calculate the recommended intravenous infusion dose for you based on your body weight.

• After the initial intravenous dose, you will receive the next dose of 90 mg of Otulfi via an injection under the skin (subcutaneous injection) 8 weeks later, and then every 12 weeks thereafter.

How Otulfi is administered

The first dose of Otulfi for the treatment of Crohn's disease is administered by a doctor via a drip in a vein in your arm (intravenous infusion).

Consult with your doctor if you have any questions about treatment with Otulfi.

If you forget to use Otulfi

If you forget a dose or miss an appointment, talk to your doctor to schedule another appointment.

If you interrupt treatment with Otulfi

Stopping Otulfi is not hazardous. However, if you stop, your symptoms may return.

If you have any other questions about using this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Severe side effects

Some patients may experience severe side effects that may require urgent treatment.

Allergic reactions – these may require urgent treatment. Contact your doctor or seek immediate medical help if you notice any of the following signs.

• Severe allergic reactions (“anaphylaxis”) are rare in the population using ustekinumab (can affect up to 1 in 1,000 people). The signs include:

• Difficulty breathing and swallowing
• Low blood pressure, which can cause dizziness or mild headaches
• Swelling of the face, lips, mouth, or throat

• Common signs of an allergic reaction include skin rash and urticaria (these can affect up to 1 in 100 people).

Reactions related to infusion – If you are being treated for Crohn's disease, the first dose of Otulfi is administered through a drip in a vein (intravenous infusion). Some patients have experienced severe allergic reactions during the infusion of ustekinumab.

In rare cases, pulmonary allergic reactions and lung inflammation have been reported in patients treated with ustekinumab. Inform your doctor immediately if you have symptoms such as coughing, difficulty breathing, and fever.

If you have a severe allergic reaction, your doctor may decide that you should not use Otulfi again.

Infections – these may require urgent treatment. Contact your doctor immediately if you notice any of these signs.

• Common colds and sore throats are frequent (can affect up to 1 in 10 people).
• Chest infections are rare (can affect up to 1 in 100 people).
• Cellulitis (inflammation of the tissues under the skin) is rare (can affect up to 1 in 100 people).
• Herpes (a painful rash with blisters) is rare (can affect up to 1 in 100 people).

Otulfi may affect your ability to fight infections. Some of them may be severe and caused by viruses, fungi, bacteria (including tuberculosis) or parasites, and include opportunistic infections that occur mainly in people with weakened immune systems. Opportunistic infections of the brain (encephalitis, meningitis), lungs, and eyes have been reported in patients receiving ustekinumab treatment.

You should monitor signs of infection while using Otulfi. These include:

• Fever, flu-like symptoms, night sweats, weight loss
• Feeling tired or difficulty breathing; persistent coughing
• Having hot, red, and painful skin or having a painful skin rash with blisters
• Urinary burning
• Diarrhea
• Visual deterioration or loss of vision
• Headache, neck stiffness, photosensitivity, nausea, or confusion.

Inform your doctor immediately if you notice any of these signs of infection, as they may be signs of infections such as pneumonia, skin infections, herpes, or opportunistic infections that could have serious complications. You should also inform your doctor if you have any type of infection that does not disappear or reappears. Your doctor may decide that you should not use Otulfi until the infection has cleared up. You should also contact your doctor if you have any open wounds or ulcers that may become infected.

Skin peeling – increased redness and skin peeling on a large area of the body may be symptoms of psoriasis erythroderma or dermatitis exfoliativa, which are serious skin disorders. If you notice any of these symptoms, you should inform your doctor immediately.

Other side effects

Frequent side effects(can affect up to 1 in 10 people):

• Diarrhea
• Nausea
• Vomiting
• Feeling tired
• Dizziness
• Headache
• Itching (“pruritus”)
• Back, muscle, or joint pain
• Sore throat
• Redness and pain at the injection site
• Sinusitis

Rare side effects(can affect up to 1 in 100 people):

• Dental infections
• Vaginal yeast infections
• Depression
• Nasal congestion or blockage
• Bleeding, petechiae, hardening, swelling, and itching at the injection site
• Feeling weak
• Drooping eyelid and facial muscle weakness (“facial paralysis” or “Bell's palsy”), which is usually temporary
• A change in psoriasis with redness and new small skin blisters, sometimes accompanied by fever (psoriasis pustular)
• Skin peeling (exfoliation of the skin)
• Acne

Very rare side effects(can affect up to 1 in 1,000 people):

• Redness and skin peeling on a large area of the body, which can cause itching or pain (dermatitis exfoliativa). Similar symptoms may develop as a natural change in psoriasis symptoms (psoriasis erythroderma)
• Inflammation of small blood vessels, which can cause a skin rash with small red or purple bumps, fever, or joint pain (vasculitis)

Extremely rare side effects(can affect up to 1 in 10,000 people)

• Blisters on the skin, which can be red and cause itching and pain (pemphigoid bullous).
• Cutaneous lupus or lupus-like syndrome (red, elevated, and scaly skin rash in sun-exposed areas, possibly accompanied by joint pain).

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national reporting system included in theAppendixV.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• Otulfi 130 mg concentrated solution for infusion is administered in a hospital or medical center and does not require patients to conserve or handle it.
• Maintain this medication out of sight and reach of children.
• Store in refrigerator (2 °C and 8 °C). Do not freeze.
• Store the vial in the outer packaging to protect it from light.
• Do not shake the vials of Otulfi. Prolonged vigorous shaking may damage the product.

Do not use this medication:

• After the expiration date appearing on the label and packaging after “CAD”. The expiration date is the last day of the month indicated.
• If the liquid changes color, becomes turbid, or presents foreign particles floating in it (see section 6 “Appearance of Otulfi and contents of the packaging”).
• If you know or suspect you have been exposed to extreme temperatures (such as accidental heating or freezing).
• If the product has been vigorously shaken.
• If the seal is broken.

Otulfi is for single use. Dispose of the unused diluted infusion solution remaining in the vial or syringe in accordance with local regulations.

Composition of Otulfi

• The active ingredient is ustekinumab. Each vial contains 130mg of ustekinumab in 26ml.
• The other components are disodium edetate, L‑histidine, monochloride of L‑histidine monohydrate, L‑methionine, polisorbate 80, sucrose, and water for injectable preparations.

Appearance of Otulfi and contents of the package

Otulfi is a concentrate for infusion solution that is transparent, colorless, or slightly yellowish in color. It is presented in a package containing 1vial of 30ml of glass single-use vial. Each vial contains 130mg of ustekinumab in 26ml of concentrate for infusion solution.

Holder of the Marketing Authorization

Fresenius Kabi Deutschland GmbH

Else‑Kroener‑Strasse1

61352Bad Homburg v.d.Hoehe

Germany

Responsible for manufacturing

Fresenius Kabi Austria GmbH

Hafnerstraße36

8055Graz Austria

Last review date of this leaflet

The detailed information on this medicine is available on the website of the European Medicines Agency:https://www.ema.europa.eu/

This information is intended exclusively for healthcare professionals:

Traceability:

In order to improve the traceability of biological medicines, the name and batch number of the administered medicine must be clearly recorded.

Dilution instructions:

Otulfi concentrate for infusion solution must be diluted, prepared, and infused by a healthcare professional using an aseptic technique.

1.Calculate the dose and the number of vials of Otulfi needed based on the patient's weight (see section3, Table1). Each vial of 26ml of Otulfi contains 130mg of ustekinumab.

2.Draw out and then discard a volume of 0.9% sodium chloride solution from the infusion bag of 250ml equivalent to the volume of Otulfi to be added (discard 26ml of sodium chloride for each vial of Otulfi needed: for 2vials, discard 52ml; for 3vials, discard 78ml; for 4vials, discard 104ml).

3.Draw out 26ml of Otulfi from each vial needed and add it to the 250ml infusion bag. The final volume of the infusion bag must be 250ml. Mix gently.

4.Perform a visual inspection of the diluted solution before infusion. Do not use if opaque particles, color changes, or foreign particles are detected.

5.Infuse the diluted solution over a minimum period of one hour. Once diluted, the infusion must be completed within 24hours after dilution in the infusion bag.

6.Use only a perfusion system with an in-line filter, sterile, apyrogenic, and low protein binding (pore size of 0.2micrometers).

7.Each vial is for single use only, and the unused medicine must be discarded in accordance with local regulations.

Storage

If necessary, the diluted infusion solution can be stored at room temperature. The infusion must be completed within 8hours after dilution in the infusion bag. Do not freeze.