Patient leaflet - Otulfi 45 mg solution for injection in Pre-filled pen
1. What Otulfi is and what it is used for
What Otulfi is
Otulfi contains the active substance ‘ustekinumab’, a monoclonal antibody. Monoclonal antibodies are proteins that recognise and bind specifically to certain proteins in the body.
Otulfi belongs to a group of medicines called ‘immunosuppressants’. These medicines work by weakening part of the immune system.
What Otulfi is used for
Otulfi administered using pre-filled pen is used to treat the following inflammatory diseases:
- Plaque psoriasis - in adults
- Psoriatic arthritis - in adults
- Moderate to severe Crohn’s disease - in adults
- Moderate to severe ulcerative colitis - in adults
Plaque psoriasis
Plaque psoriasis is a skin condition that causes inflammation affecting the skin and nails. Otulfi will reduce the inflammation and other signs of the disease.
Otulfi administered using pre-filled pen is used in adults with moderate to severe plaque psoriasis, who cannot use ciclosporin, methotrexate or phototherapy, or where these treatments did not work.
Psoriatic arthritis
Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis. If you have active psoriatic arthritis you will first be given other medicines. If you do not respond well enough to these medicines, you may be given Otulfi to:
- Reduce the signs and symptoms of your disease.
- Improve your physical function.
- Slow down the damage to your joints.
Crohn’s disease
Crohn’s disease is an inflammatory disease of the bowel. If you have Crohn’s disease you will first be given other medicines. If you do not respond well enough or are intolerant to these medicines, you may be given Otulfi to reduce the signs and symptoms of your disease.
Ulcerative colitis
Ulcerative colitis is an inflammatory disease of the bowel. If you have ulcerative colitis, you will first be given other medicines. If you do not respond well enough or are intolerant to these medicines, you may be given Otulfi to reduce the signs and symptoms of your disease
2. What you need to know before you use Otulfi
Do not use Otulfi
- If you are allergic to ustekinumab or any of the other ingredients of this medicine (listed in section 6).
- If you have an active infection which your doctor thinks is important.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Otulfi.
Warnings and precautions
Talk to your doctor or pharmacist before using Otulfi. Your doctor will check how well you are before each treatment. Make sure you tell your doctor about any illness you have before each treatment. Also tell your doctor if you have recently been near anyone who might have tuberculosis. Your doctor will examine you and do a test for tuberculosis, before you have Otulfi. If your doctor thinks you are at risk of tuberculosis, you may be given medicines to treat it.
Look out for serious side effects
Otulfi can cause serious side effects, including allergic reactions and infections. You must look out for certain signs of illness while you are taking Otulfi. See ‘Serious side effects’ in section 4 for a full list of these side effects.
Before you use Otulfi tell your doctor:
- If you ever had an allergic reaction to ustekinumab. Ask your doctor if you are not sure.
- If you have ever had any type of cancer – this is because immunosuppressants like Otulfi weaken part of the immune system. This may increase the risk of cancer.
If you have been treated for psoriasis with other biologic medicines (a medicine produced from a biological source and usually given by injection)
- the risk of cancer may be higher.
- If you have or have had a recent infection.
- If you have any new or changing lesions within psoriasis areas or on normal skin.
- If you have ever had an allergic reaction to Otulfi injection –See ‘Look out for serious side effects’ in section 4 for the signs of an allergic reaction. • If you are having any other treatment for psoriasis and/or psoriatic arthritis – such as another 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. Using these therapies together with Otulfi has not been studied. However it is possible it may increase the chance of diseases related to a weaker immune system.
- If you are having or have ever had injections to treat allergies – it is not known if Otulfi may affect these.
- If you are 65 years of age or over – you may be more likely to get infections.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Otulfi.
Some patients have experienced lupus-like reactions including skin lupus or lupus-like syndrome during treatment with ustekinumab. Talk to your doctor right away if you experience a red, raised, scaly rash sometimes with a darker border, in areas of the skin that are exposed to the sun or with joint pains.
Heart attack and strokes
Heart attack and strokes have been observed in a study in patients with psoriasis treated with ustekinumab. Your doctor will regularly check your risk factors for heart disease and stroke in order to ensure that they are appropriately treated. Seek medical attention right away if you develop chest pain, weakness or abnormal sensation on one side of your body, facial droop, or speech or visual abnormalities.
Children and adolescents
The Otulfi pre-filled pen is not recommended for use in children and adolescents under 18 years of age with psoriasis or Crohn’s disease because it has not been studied in this age group. The pre-filled syringe or vial should be used instead for children 6 years of age and older and adolescents with psoriasis. The solution for infusion, pre-filled vial or syringe should be used instead for children weighing at least 40 kg with Crohn’s disease.
Otulfi is not recommended for use in children and adolescents under 18 years of age with psoriatic arthritis, or ulcerative colitis or children with Crohn’s disease who weigh less than 40 kg because it has not been studied in this age group.
Other medicines, vaccines and Otulfi
Tell your doctor or pharmacist:
- If you are taking, have recently taken or might take any other medicines. • If you have recently had or are going to have a vaccination. Some types of vaccines (live vaccines) should not be given while using Otulfi. • If you received Otulfi while pregnant, tell your baby’s doctor about your Otulfi treatment 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 twelve months after birth if you received Otulfi during the pregnancy unless your baby’s doctor recommends otherwise.
Pregnancy and breast-feeding
- If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
A higher risk of birth defects has not been seen in babies exposed to ustekinumab in the womb. However, there is limited experience with ustekinumab in pregnant women. It is therefore preferable to avoid the use of
Otulfi in pregnancy.
- If you are a woman of childbearing potential, you are advised to avoid becoming pregnant and must use adequate contraception while using Otulfi and for at least 15 weeks after the last Otulfi treatment.
- Ustekinumab can pass across the placenta to the unborn baby. If you received Otulfi during your pregnancy, your baby may have a higher risk for getting an infection.
- It is important that you tell your baby’s doctors and other health care professionals if you received Otulfi during your pregnancy before the baby receives any vaccine. Live vaccines such as the BCG vaccine (used to prevent tuberculosis) are not recommended for your baby in the first twelve months after birth if you received Otulfi during the pregnancy unless your baby’s doctor recommends otherwise.
- Ustekinumab may pass into breast milk in very small amounts. Talk to your doctor if you are breast-feeding or are planning to breast-feed. You and your doctor should decide if you should breast-feed or use Otulfi - do not do both.
Driving and using machines
Otulfi has no or negligible influence on the ability to drive and use machines.
Otulfi contains polysorbate 80
This medicine contains 0.02 mg of polysorbate 80 in each pre-filled pen of 0.5 ml which is equivalent to 0.04 mg/ml. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.
3. How to use Otulfi
Otulfi is intended for use under the guidance and supervision of a doctor experienced in treating conditions for which Otulfi is intended. Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. Talk to your doctor about when you will have your injections and follow-up appointments.
How much Otulfi is given
Your doctor will decide how much Otulfi you need to use and for how long.
Adults aged 18 years or older
Psoriasis or Psoriatic Arthritis
- The recommended starting dose is 45 mg Otulfi. Patients who weigh more than 100 kilograms (kg) may start on a dose of 90 mg instead of 45 mg. • After the starting dose, you will have the next dose 4 weeks later, and then every 12 weeks. The following doses are usually the same as the starting dose.
Crohn’s disease or Ulcerati
- During treatment, the first by your doctor through a d After the starting dose, yo 8 weeks, then every 12 we (‘subcutaneously’).
- In some patients, after the given every 8 weeks. Your next dose.
How Otulfi is given
Otulfi is given as an injecti your treatment, medical or • However, you and your doc In this case you will get tra • For instructions on how to the end of this leaflet. Talk to your doctor if you ha
ve Colitis
dose of approximately 6 mg/kg Otulfi will be given rip in a vein in your arm (intravenous infusion). u will receive the next dose of 90 mg Otulfi after eks thereafter by an injection under the skin
first injection under the skin, 90 mg Otulfi may be doctor will decide when you should receive your
on under the skin (‘subcutaneously’). At the start of nursing staff may inject Otulfi.
tor may decide that you may inject Otulfi yourself. ining on how to inject Otulfi yourself.
inject Otulfi, see ‘Instructions for administration’ at
ve any questions about giving yourself an injection.
If you use more Otulfi than
If you have used or been giv straight away. Always have t is empty.
If you forget to use Otulfi
If you forget a dose, contact dose to make up for a forgot
If you stop using Otulfi
It is not dangerous to stop us may come back. If you have ask your doctor or pharmaci
4. Possible side effec
Like all medicines, this medic gets them.
you should
en too much Otulfi, talk to a doctor or pharmacist he outer carton of the medicine with you, even if it
your doctor or pharmacist. Do not take a double ten dose.
ing Otulfi. However, if you stop, your symptoms any further questions on the use of this medicine, st.
ts
ine can cause side effects, although not everybody
Serious side effects
Some patients may have seri
Allergic reactions – these m get emergency medical hel signs.
- Serious allergic reactions ( (may affect up to 1 in 1,000 ◦ difficulty breathing or sw ◦ low blood pressure, whic ◦ swelling of the face, lips, • Common signs of an allerg affect up to 1 in 100 people
In rare cases, allergic lung reported in patients who re you develop symptoms suc
ous side effects that may need urgent treatment.
ay need urgent treatment. Tell your doctor or p straight away if you notice any of the following
‘anaphylaxis’) are rare in people taking ustekinumab people). Signs include:
allowing
h can cause dizziness or light-headedness mouth or throat.
ic reaction include skin rash and hives (these may ).
reactions and lung inflammation have been ceive ustekinumab. Tell your doctor right away if h as cough, shortness of breath, and fever.
If you have a serious allergic not use Otulfi again.
Infections – these may nee away if you notice any of th
- Infections of the nose or t to 1 in 10 people)
- Infections of the chest are • Inflammation of tissue und to 1 in 100 people)
- Shingles (a type of painful 1 in 100 people)
Otulfi may make you less abl serious and may include infe tuberculosis), or parasites, in a weakened immune system of the brain (encephalitis, me patients receiving treatment
reaction, your doctor may decide that you should
d urgent treatment. Tell your doctor straight e following signs.
hroat and common cold are common (may affect up
uncommon (may affect up to 1 in 100 people) er the skin (‘cellulitis’) is uncommon (may affect up
rash with blisters) are uncommon (may affect up to
e to fight infections. Some infections could become ctions caused by viruses, fungi, bacteria (including cluding infections that mainly occur in people with (opportunistic infections). Opportunistic infections ningitis), lungs, and eye have been reported in with ustekinumab.
You must look out for signs of infection while you are using Otulfi. These include: • fever, flu-like symptoms, night sweats, weight loss
- feeling tired or short of breath; cough which will not go away • warm, red and painful skin, or a painful skin rash with blisters • burning when passing water
- diarrhoea
- visual disturbance or vision loss
headache, neck stiffness, light sensitivity, nausea or confusion.
Tell your doctor straight away if you notice any of these signs of infection. These may be signs of infections such as chest infections, skin infections, shingles or opportunistic infections that could have serious complications. Tell your doctor if you have any kind of infection that will not go away or keeps coming back. Your doctor may decide that you should not use Otulfi until the infection goes away. Also tell your doctor if you have any open cuts or sores as they might get infected.
Shedding of skin – increase in redness and shedding of skin over a larger area of the body may be symptoms of erythrodermic psoriasis or exfoliative dermatitis, which are serious skin conditions. You should tell your doctor straight away if you notice any of these signs.
Other side effects
Common side effects (may affect up to 1 in 10 people):
- Diarrhoea
- Nausea
- Vomiting
- Feeling tired
- Feeling dizzy
- Headache
- Itching (‘pruritus’)
- Back, muscle or joint pain
- Sore throat
- Redness and pain where the injection is given • Sinus infection
Uncommon side effects (may affect up to 1 in 100 people
):
- Tooth infections
- Vaginal yeast infection
- Depression
- Blocked or stuffy nose
Bleeding, bruising, hardness, swelling and itching where
the injection is given
- Feeling weak
- Drooping eyelid and sagging muscles on one side of the face (‘facial palsy’ or ‘Bell’s palsy’), which is usually temporary
- A change in psoriasis with redness and new tiny, yellow or white skin blisters, sometimes accompanied by fever (pustular psoriasis) • Peeling of the skin (skin exfoliation)
- Acne
Rare side effects (may affect up to 1 in 1 000 people) • Redness and shedding of skin over a larger area of the body, which may be itchy or painful (exfoliative dermatitis). Similar symptoms sometimes develop as a natural change in the type of psoriasis symptoms (erythrodermic psoriasis)
- Inflammation of small blood vessels, which can lead to a skin rash with small red or purple bumps, fever or joint pain (vasculitis)
Very rare side effects (may affect up to 1 in 10,000 people)
- Blistering of the skin that may be red, itchy, and painful (Bullous pemphigoid).
- Skin lupus or lupus-like syndrome (red, raised scaly rash on areas of the skin exposed to the sun possibly with joint pains).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: www.mhra. gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Otulfi
- Keep this medicine out of the sight and reach of children.
Store in a refrigerator (2 °C – 8 °C). Do not freeze. • Keep the pre-filled pen in the outer carton in order to pr
otect from light.
If needed, individual Otulfi pre-filled pens may also be s
tored at room temperature up to 30 °C for a maximum single period o
f up to 30 days in the original carton in order to protect from light. Record the
date when the pre-filled pen is first removed from the refrigerator in the sp
ace provided on the outer carton. At any time before the end of this period,
the product can be put back in the refrigerator once and kept there until the ex
piry date. Discard the pre-filled pen if not used within 30 days at room temper
ature storage or by the original expiry date, whichever is earlier. • Do not shake Otulfi pre-filled pens. Prolonged vigorous
shaking may damage the medicine.
Do not use this medicine:
After the expiry date which is stated on the label and th
e carton after ‘EXP’.
The expiry date refers to the last day of that month. • If the liquid is discoloured, cloudy or you can see other f
oreign particles floating in it (see section 6 ‘What Otulfi looks like and co
ntents of the pack’). • If you know, or think that it may have been exposed to extreme temperatures (such as accidentally frozen or heated).
- If the product has been shaken vigorously.
Otulfi is for single use only. Any unused product remaining in the pen should be thrown away. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Otulfi contains
- The active substance is ustekinumab. Each pre-filled pen contains 45 mg ustekinumab in 0.5 mL.
- The other ingredients are L-histidine, polysorbate 80 (E433), sucrose, water for injections and hydrochloric acid (to adjust pH).
What Otulfi looks like and contents of the pack
Otulfi is a clear, colourless to slightly brown-yellow solution for injection. It is supplied as a carton pack containing 1 single-dose, glass 1 mL pre-filled pen Each pre-filled pen contains 45 mg ustekinumab in 0.5 mL of solution for injection.
Marketing Authorisation Holder
Fresenius Kabi Limited
Cestrian Court
Eastgate Way, Manor Park
Runcorn, Cheshire, WA7 1NT
United Kingdom
Manufacturer
Fresenius Kabi Austria GmbH
Hafnerstraße 36
8055 Graz
Austria
This leaflet was last revised in May 2026.
solution for injection in pre-filled pen ustekinumab
Subcutaneous use
45 mg
45 mg/0.5 mL
solution for injection in pre-filled pen
ustekinumab
Subcutaneous use
45 mg
45 mg/0.5 mL
This “Instructions for Use” contains information on how to inject OTULFI using the 45 mg/0.5 mL single dose pre-filled pen (OTULFI pre-filled pen). Read and follow the Instructions for Use that come with your OTULFI pre-filled pen before you start using it and each time you get a refill. There may be new information. This information does not replace talking to your doctor or pharmacist about your medical condition or treatment. If you have any questions about using your OTULFI pre-filled pen, please call your doctor or pharmacist.
Important information you need to know before injecting OTULFI
- Read the package leaflet that comes with your OTULFI pre-filled pen for important information you need to know before using it. • For subcutaneous injection only (inject directly under the skin). • If your doctor decides that you or a caregiver can give your OTULFI injection at home, you should receive training on the right way to prepare and inject OTULFI. Do not try to inject OTULFI yourself until you have been shown the
right way to give the injections by your doctor or nurse. - Do not reuse the OTULFI pre-filled pen. The OTULFI pre-filled pen is for single-dose (one-time) use only.
- Do not share your OTULFI pre-filled pen with another person. You may give another person an infection or get an infection from them. • Do not remove the clear cap from the OTULFI pre-filled pen until you are ready to inject OTULFI.
- Do not use the OTULFI pre-filled pen if it shows any signs of damage or if it has been dropped.
- Do not try to take apart the OTULFI pre-filled pen at any time.
Storing OTULFI pre-filled pens
- Store OTULFI pre-filled pens in the refrigerator between 2°C to 8°C.
• Store unused OTULFI pre-filled pens in the original carton to protect from light. - Do not freeze OTULFI pre-filled pen. Do not use OTULFI pre-filled pen if it was frozen.
Do not expose OTULFI pre-filled pen to heat or direct sunlight. • Do not shake OTULFI pre-filled pen.
- Prolonged vigorous shaking may damage the medicine. - Do not use the OTULFI pre-filled pen if it has been shaken. • OTULFI pre-filled pen may be stored at room temperature up to 30°C in the original carton for up to 30 days.
- Do not use OTULFI pre-filled pen if it has been out of the refrigerator for more than 30 days.
At any time before the end of this period, OTULFI pre-filled pen can be put back in the refrigerator once and kept there until the expiry date. Discard the pre-filled pen if not used after the maximum period of 30 days at room temperature storage or by the original expiry date, whichever is earlier. • When traveling on an airplane, always store OTULFI pre-filled pen in your carry-on luggage because the airplane luggage area can be very cold and OTULFI could freeze.
Your OTULFI pre-filled pen
Before Use
Clear Cap Viewing
Window Body
Expiration
Date
Purple
Indicator
Medicine
Purple indicator partially visible in the viewing window is normal
EXP: MMM/YYYY
After Use
Needle
Cover
Viewing
Window Body
Purple Indicator
(View Window Completely Filled)
EXP: MMM/YYYY
Preparing for your injection Step 1
Choose a clean, flat surface, such as a
table or countertop, in a well-lit area.
Gather the following supplies (not
included) (see Figure A):
- a sterile cotton ball or gauze
- an alcohol pad
a sharps disposal container
(see Step 9)
Remove the carton containing the OTULFI pre-filled pen from the
refrigerator.
Before you start, check the carton to make sure that it is the right medicine and dose. You will have either a 45 mg dose or 90 mg dose as prescribed by your doctor.
If your dose is 45 mg, you will receive one 45 mg OTULFI pre-filled pen. - If your dose is 90 mg, you will receive either one 90mg OTULFI pre-
filled pen or two 45 mg OTULFI pre-filled pens.
If you receive two 45 mg OTULFI pre-filled pens for a 90 mg dose:
- Follow Steps 1 through 7 for both injections.
Choose two different sites for these injections (for example one
injection in the right thigh and the other injection in the left thigh) and give the injections one right after the other.
Check the carton to make sure that it
is the medicine and dose that you are
prescribed.
Check the expiration date (EXP) on the
carton to make sure the date has not
passed (see Figure B).
Check the carton for any signs of
damage.
Do not use the OTULFI pre-filled pen if it looks
like the carton has been opened.
Let the carton sit on the chosen surface
for 45 minutes before use to allow the
medicine in the OTULFI pre-filled pen to
reach room temperature (see Figure C).
Do not warm OTULFI pre-filled pen in any
other way, such as in a microwave, hot water, or direct sunlight.
- Remove the OTULFI pre-filled pen from carton.
Do not remove the clear cap from the OTULFI pre-filled pen until you are ready to inject to avoid injury.
Check your OTULFI pre-filled pen Step 2
Check the OTULFI pre-filled pen to make
sure it is not cracked or damaged (see
Figure D).
Note: It is normal to see the purple
indicator partially visible in the viewing
window.
Do not use if the OTULFI pre-filled pen shows signs of damage or if it has been dropped.
Check the OTULFI pre-filled pen label to make sure that:
The name on the pre-filled pen says OTULFI. - The dose on the OTULFI pre-filled pen
is what you are prescribed.
The expiration date (EXP) on the
OTULFI pre-filled pen has not passed
(see Figure E).
Do not use the pre-filled pen if the name
on the label is not OTULFI, the dose is not what you are prescribed, or the expiration date on the label has passed.
Look at the medicine in the viewing
window. Make sure it is clear and
colourless to slightly brown-yellow
and does not contain any particles (see
Figure F).
Note: Air bubbles in the medicine are
normal.
Do not inject OTULFI if the medicine is frozen, cloudy, discoloured, or has lumps or particles in it because it may not be safe to use. Call your doctor or pharmacist for instructions.
Wash your hands Step 3
Wash your hands well with soap and
water, then dry them with a clean towel
(see Figure G).
Choose the injection site Step 4
If you are giving yourself the injection,
you can use:
- The front of your upper thigh.
The belly (abdomen), except within
5 cm around the belly button (navel).
If a caregiver is giving the injection,
they can also use the outer area of
the upper arm (see Figure H).
Note: Rotate to a different injection site
(such as other leg, other side of the belly,
etc.) for every injection.
Do not inject into skin that is sore (tender), bruised, red, or hard.
Do not inject through clothing.
Clean the injection site Step 5
Wipe the skin where you want to inject
with an alcohol pad to clean it (see
Figure I). Let the skin dry.
Do not blow on or touch the site after
cleaning.
Give your injection Step 6
When you are ready to inject, position the
OTULFI pre-filled pen in your hand so you can
clearly see the viewing window
Using your other hand, firmly pull the clear cap
straight off without twisting (see Figure J).
Note: A few drops of medicine may come out
of the needle, this is normal.
Note: Use the OTULFI pre-filled pen within 3 minutes after removing the clear cap to avoid contamination.
Do not try to put the clear cap back on the OTULFI pre-filled pen at any time, even at the end of the injection.
Do not touch the needle cover (the purple-coloured part located at the tip of the OTULFI pre-filled pen) because this might cause an accidental needle stick.
Throw away the clear cap in a sharps disposal container
(see Step 9).
Read all of the remaining instructions in Step 6 before you start injecting to make sure you give the full dose.
Place the purple needle cover of the
OTULFI pre-filled pen straight against
your skin at a 90-degree angle. Make sure
that you can see the viewing window (see
Figure K).
Note: To make sure you inject under the
skin (into the fatty tissue) do not tilt the
OTULFI pre-filled pen.
In a single motion, push and hold the
OTULFI pre-filled pen firmly against your
skin until you hear a first click. This
means the injection has started (see
Figure L).
Look at the viewing window to make sure
that the purple indicator is moving during
the injection.
Continue pushing the OTULFI pre-filled
pen down on the injection site and listen
for a second click which means that the
injection is almost complete. This may
take between 5 to 20 seconds (see
Figure M).
Do not lift the OTULFI pre-filled pen from
the skin when you hear the second click
because the medicine may not be fully
injected.
After you hear the second click, continue
holding the OTULFI pre-filled pen in place
and slowly count to 5 (see Figure N).
While holding the OTULFI pre-filled pen
in place, check to make sure the purple
indicator has fully appeared in the viewing
window and has stopped moving (see
Figure O).
Do not try to repeat the injection with
a new OTULFI pre-filled pen if the purple indicator did not come all the way down during the injection or you believe you did not get a full injection. Call your doctor or pharmacist if this happens.
Remove the OTULFI pre-filled pen from your skin
Step 7
When the injection is complete, lift the
OTULFI pre-filled pen straight away from your skin (see Figure P).
Note: The purple needle cover will slide down and cover the needle.
Do not put the clear cap back on the
OTULFI pre-filled pen.
If you see blood on the injection site, press gauze or a cotton ball on the skin until the bleeding stops (see Figure Q).
Do not rub the injection site.
Throw away your used OTULFI pre-filled pen as described in Step 9 and Figure R.
If a second 45 mg injection is needed for a 90 mg dose, repeat Steps 1 through 7 Step 8
If you receive two 45 mg OTULFI pre-filled pens for a 90 mg dose, give the second injection right after the first.
Repeat Steps 1 through 7 with the second OTULFI pre- filled pen. • Choose two different sites for these injections (for example one injection in the right thigh and the other injection in the left thigh) and give the injections one right after the other.
Throwing away (disposing of) your OTULFI pre-filled pen Step 9
Used OTULFI pre-filled pen and clear cap should be placed in a puncture-resistant container, like a sharps container right away after use (see Figure R).
Do not put the clear cap back on the OTULFI pre-filled pen.
Do not throw away (dispose of) your OTULFI pre-filled pen in your household waste.
Any unused medicinal product or waste material and the sharps container should be disposed of in accordance with local requirements. Antiseptic wipes and other supplies can be disposed of in your garbage.
Always keep the sharps disposal container out of reach of children. Keep OTULFI pre-filled pen and all medicines out of the reach of children.
M0FOx45/X1 UK Instructions for use
Otulfi 45 mg
solution for injection in pre-filled pen
ustekinumab
Figure A Sterile cotton ball
Alcohol pad
Sharps Disposal
Figure B EXP: MMM/ YYYY
EXP: MMM/YYYY
Month/Year
Figure C
EXP: MMM/YYYY
45minutes
Figure E EXP: MMM/YYYY
EXP: MMM/YYYY
Figure F Correct
Incorrect
Particles
Figure G
Figure H
Self or caregiver
Caregiver ONLY
Figure J
90°
Figure K
Figure O
Figure P
Figure Q
Figure L
Figure M
Start of injection
Injection is ongoing
Figure N
End of injection
Slowly count to 5
2nd
CLICK
1st
CLICK
5-20seconds
Figure D EXP: MMM/YYYY
verw bis MM/JJJJ
Figure I
Sharps
Disposal
Figure R