Patient Medication Information: uses, side effects, how to take - Hyrimoz

Serious Warnings and Precautions

Allergic reactions: If you develop a severe rash, swollen face or difficulty breathing while taking Hyrimoz, call your doctor right away.
Hepatosplenic T-cell lymphoma: Very rare reports of hepatosplenic T-cell lymphoma (HSTCL), a rare serious lymphoma that is often fatal, have been identified in patients treated with adalimumab. Most patients had also been treated with other medications for Crohn’s disease and the majority were in adolescent and young adult males. The link between HSTCL and adalimumab is not clear.
Other cancers: There have been very rare cases of certain kinds of cancer in patients taking adalimumab or other TNF-blockers. Some patients receiving adalimumab have developed types of cancer called non-melanoma skin cancer. Tell your doctor if you have a bump or open sore that does not heal. People with more serious rheumatoid arthritis that have had the disease for a long time may have a higher than average risk of getting a kind of cancer that affects the lymph system, called lymphoma. If you take Hyrimoz or other TNF-blockers, your risk may increase. There have been cases of lymphoma and other cancers, including unusual types, in children, adolescents and young adults taking TNF-blocking agents, including adalimumab, which sometimes resulted in death. For children and adults taking TNF-blocker medicines, the chances of developing lymphoma or other cancers may increase.
Lupus-like symptoms: Some patients have developed lupus-like symptoms that got

What is Hyrimoz used for?

Hyrimoz treatment should be started and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), adult and pediatric Crohn’s disease (CD), adult and pediatric ulcerative colitis (UC), adult and adolescent hidradenitis suppurativa (HS), psoriasis (Ps) or adult and pediatric uveitis, and familiar with the Hyrimoz efficacy and safety profile.

Hyrimoz is a medicine that is used in:

adults with rheumatoid arthritis, which is an inflammatory disease of the joints.
adults with psoriatic arthritis, which is an inflammatory disease of the joints and skin.
adults with ankylosing spondylitis, which is a form of arthritis.
adults with Crohn’s disease, which is an inflammatory disease of the digestive tract.
patients 2 years of age and older who have polyarticular juvenile idiopathic arthritis.
children 13 to 17 years weighing ≥ 40 kg who have severe Crohn’s disease or who have Crohn’s disease which has not responded to other usual treatments.
adults with ulcerative colitis, which is an inflammatory disease of the bowel (colon).
adults or adolescents (12 to 17 years of age, weighing ≥ 30 kg) with moderate to severe hidradenitis suppurativa (HS) who have not responded to antibiotics. HS is a painful, progressive, chronic inflammatory skin disease that causes nodules, abscesses, sinus tracts and fistulas under the breasts, underarms, buttocks and groin.
adults with psoriasis, which is an inflammatory disease of the skin. The doctor prescribed

better after their treatment was stopped. If you have chest pains that do not go away, shortness of breath, joint pain or a rash on your cheeks or arms that gets worse in the sun, call your doctor right away. Your doctor may decide to stop your treatment.
Nervous system diseases: There have been rare cases of disorders that affect the nervous system of people taking adalimumab or other TNF-blockers. Signs that you could be experiencing a problem affecting your nervous system include: numbness or tingling, problems with your vision, weakness in your legs, and dizziness.
Serious infections: There have been rare cases where patients taking adalimumab or other TNF-blocking agents have developed serious infections. Some of these cases have been life-threatening. Such infections include tuberculosis, infections caused by bacteria or fungi, and bacterial infections that have spread throughout the body (sepsis). Infection causes include tuberculosis, legionellosis (a serious form of bacterial pneumonia), listeriosis (an infection that usually develops after eating food contaminated by bacteria called listeria), and very rare cases of hepatitis B infection relapse.
Blood problems: In some instances, patients treated with TNF-blocking agents may develop low blood counts, such as anemia (low red blood cells) or low platelets. If you develop symptoms such as persistent fever, bleeding, or bruising, you should contact your doctor right away.

Hyrimoz to reduce the signs and symptoms of your plaque psoriasis.
adults with uveitis, which is an inflammatory disease of the eye.
children with chronic non-infectious uveitis from 2 years of age with inflammation affecting the front of the eye.
Children 5 to 17 years of age who have ulcerative colitis

Patients with rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, hidradenitis suppurativa, psoriasis, or uveitis may be given other medicines for their disease before they are given Hyrimoz. If you have ulcerative colitis or you have Crohn’s disease, you will first be given other medicines. If you do not respond well enough to these medicines, you will be given Hyrimoz to reduce the signs and symptoms of your disease.

How does Hyrimoz work?

Hyrimoz is a fully human monoclonal antibody produced by cultured cells. Monoclonal antibodies are proteins that recognize and bind to other unique proteins. Hyrimoz binds to a specific protein called TNF-alpha (also known as tumor necrosis factor). People with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, hidradenitis suppurativa or psoriasis have too much of TNF-alpha in their bodies. The extra TNF-alpha in your body can attack normal healthy body tissues and cause inflammation, especially in the tissues of your bones, cartilage, joints, digestive tract and skin. By binding to TNF-alpha, Hyrimoz decreases the inflammation process of these diseases.

Hyrimoz helps reduce the signs and symptoms of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and psoriatic arthritis (such as pain and swollen joints), may help improve your ability to perform daily activities (such as getting dressed, walking and climbing stairs), and may help prevent further damage to your bones and joints. In addition, Hyrimoz helps reduce the signs and symptoms of ankylosing spondylitis (back pain and morning stiffness), and adult and pediatric Crohn’s disease or adult and pediatric ulcerative colitis (abdominal pain and diarrhea). Hyrimoz may also help normalize childhood growth and pubertal development, and improve the quality of life in children who have Crohn’s disease (such as body image, functional and social skills, and emotional health). Hyrimoz may help improve the work productivity and activity impairment in caregivers of children with Crohn’s disease or ulcerative colitis.

Hyrimoz is also used to treat inflammatory lesions (nodules and abscesses) in adult and adolescents (12 to 17 years of age, weighing ≥ 30 kg) with hidradenitis suppurativa.

Hyrimoz also helps reduce the signs and symptoms of psoriasis (such as pain, itching and scaly patches on skin).

Hyrimoz helps control uveitis by reducing the risk of inflammation and loss of vision in adult and pediatric patients.

Hyrimoz, however, can also lower your body’s ability to fight infections. Taking Hyrimoz can make you more prone to getting infections or make any infection you have worse.

What are the ingredients in Hyrimoz?

Medicinal ingredient: adalimumab

Non-medicinal ingredients:

Hyrimoz (50 mg/mL): adipic acid, citric acid monohydrate, mannitol, polysorbate 80, sodium chloride and water for injection. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH.

Hyrimoz (100 mg/mL): adipic acid, mannitol, polysorbate 80, and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH.

Hyrimoz comes in the following dosage forms:

Single-dose pre-filled Hyrimoz SensoReady^®Pen Injection:

40 mg/0.8 mL of Hyrimoz is provided by a single-dose pen (SensoReady^®Pen), containing a 1 mL pre-filled glass syringe with a fixed 29-gauge, ½-inch needle and a black needle cover.

Single-dose pre-filled syringe with BD UltraSafe Passive™ Needle Guard Injection:

20 mg/0.4 mL of Hyrimoz is provided by a single-dose, 1 mL pre-filled glass syringe with a needle guard and add-on finger flange, a fixed 29-gauge, ½-inch needle and a needle cover.

40 mg/0.8 mL of Hyrimoz is provided by a single-dose, 1 mL pre-filled glass syringe with a needle guard and add-on finger flange, a fixed 29-gauge, ½-inch needle and a needle cover.

Single-dose pre-filled Hyrimoz SensoReady^®Pen Injection:

40 mg/0.4 mL of Hyrimoz is provided by a single-dose pen (SensoReady^®Pen), containing a 1 mL pre-filled glass syringe with a fixed 29-gauge, ½-inch needle and a needle cover.

80 mg/0.8 mL of Hyrimoz is provided by a single-dose pen (SensoReady^®Pen), containing a 1 mL pre-filled glass syringe with a fixed 29-gauge, ½-inch needle and a needle cover.

Single-dose pre-filled syringe with BD UltraSafe Passive™ Needle Guard Injection:

40 mg/0.4 mL of Hyrimoz is provided by a single-dose, 1 mL pre-filled glass syringe with a needle guard, plunger rod and add-on finger flange, a fixed 29-gauge, ½-inch needle and a Rigid needle shield.

80 mg/0.8 mL of Hyrimoz is provided by a single-dose, 1 mL pre-filled glass syringe with a needle guard, plunger rod and add-on finger flange, a fixed 29-gauge, ½-inch needle and a needle cover.

Single-dose pre-filled syringe with a plunger rod and backstop

20 mg/0.2 mL of Hyrimoz is provided by a single-dose, 1 mL pre-filled glass syringe with a plunger rod and backstop, a fixed 29-gauge, ½-inch needle and a needle cover.

Do not use Hyrimoz if:

You should not take Hyrimoz if you have:

an allergy to any of the ingredients in Hyrimoz (see What are the ingredients in Hyrimoz?).
a serious infection such as tuberculosis, infections caused by bacteria or fungi, and bacterial infections that have spread throughout the body (sepsis).
moderate to severe heart failure (NYHA class III/IV).

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Hyrimoz. Talk about any health conditions or problems you may have, including if:

you have or have had any kind of infection including an infection that is in only one place in your body (such as an open cut or sore), or an infection that is in your whole body (such as the flu). Having an infection could put you at risk for serious side effects from Hyrimoz. If you are unsure, ask your doctor.
you have a history of infections that keep coming back or other conditions that might increase your risk of infections, including fungal infections.
you have ever had tuberculosis, or if you have been in close contact with someone who has had tuberculosis. If you develop any of the symptoms of tuberculosis (a dry cough that doesn't go away, weight loss, fever, night sweats) call your doctor right away. Your doctor will need to examine you for tuberculosis and perform a skin test.
you resided or travelled to areas where there is a greater risk for certain kinds of infections such as tuberculosis, histoplasmosis, coccidioidomycosis, blastomycosis, or parasitic infections. These infections are caused by a bacteria or a fungus that can affect the lungs or other parts of your body. If you take Hyrimoz, these may become active or more severe. If you don’t know if you have lived in or travelled to an area where these infections are common, ask your doctor.
you have ever had liver injury or hepatitis B virus infection or are at risk of developing this infection. Signs and symptoms include the following: yellowing of the skin or eyes (jaundice), feeling of sickness, tiredness, loss of appetite, joint pain, fever, dark brown-coloured urine, vomiting, and abdominal pain. If you experience any of these signs and symptoms, contact your doctor immediately. These symptoms may occur several months after starting therapy with Hyrimoz.
you experience any numbness or tingling or have ever had a disease that affects your nervous system like multiple sclerosis or Guillain-Barré syndrome.
you have or have had heart failure.
you are scheduled to have major surgery or dental procedures.
you are scheduled to be vaccinated for anything. It is recommended that pediatric patients, if possible, be brought up to date with all immunizations according to current guidelines before starting Hyrimoz.
you are taking other medicines for your rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, psoriasis, or other conditions. You can take other medicines provided your doctor has prescribed them or has told you it is acceptable that you take them while you are taking Hyrimoz. It is important that you tell your doctor about any other medicines you are taking for other conditions (for example, high blood pressure medicine) before you start taking Hyrimoz.
you are taking other medicines for your Crohn’s disease or other conditions. You can
- take other medicines provided your doctor has prescribed them or has told you it is acceptable that you take them while you are taking Hyrimoz. It is important that you tell the doctor about any other medicines you are taking for other conditions before you start taking Hyrimoz.
you are taking any over-the-counter drugs, herbal medicines and vitamin and mineral supplements.
you are pregnant or could become pregnant.
you are breast-feeding or plan to breast-feed

If you are not sure or have any questions about any of this information, ask your doctor.

Other warnings you should know about:

Before starting, during and after treatment with Hyrimoz, you should be checked for active or inactive tuberculosis infection with a tuberculin skin test.

Any medicine can have side effects. Like all medicines that affect your immune system, Hyrimoz can cause serious side effects (see Serious Warnings and Precautions box).

If you received Hyrimoz while pregnant, your may be at higher risk for getting an infection for up to approximately five months after the last dose of Hyrimoz received during pregnancy. It is important that you tell your doctors and other healthcare professionals about your use during pregnancy so they can decide when your baby should receive any vaccine.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with Hyrimoz:

You should not take Hyrimoz with:

other TNF-blockers such as etanercept (Enbrel^®), infliximab (Remicade^®), certolizumab pegol (Cimzia^®), or golimumab (Simponi^®)
abatacept (Orencia^®)
anakinra (Kineret^®)

If you have questions, ask your doctor.

How to take Hyrimoz:

Usual dose:

Hyrimoz is administered by injection under the skin (by subcutaneous injection).

Adults with Rheumatoid Arthritis, Psoriatic Arthritis or Ankylosing Spondylitis:

The recommended dose is 40 mg administered every other week as a subcutaneous injection.

Patients, Aged 2 Years and Older, with Polyarticular Juvenile Idiopathic Arthritis:

weighing 10 kg to less than 30 kg: the recommended dose of Hyrimoz is 20 mg every
- other week.
weighing 30 kg or more: the recommended dose of Hyrimoz is 40 mg every other week.

A dose of 10 mg every other week can be considered for patients weighing 10 to <15 kg. A different adalimumab product should be considered as there are no available presentations of Hyrimoz capable of delivering 10 mg.

Adults with Crohn’s Disease or Ulcerative Colitis:

The recommended induction dose is 160 mg at Week 0 (dose can be administered as four injections in one day or as two injections per day for two consecutive days), followed by 80 mg at Week 2.
The recommended maintenance dose regimen is 40 mg every other week beginning at Week 4.

Adults with Hidradenitis Suppurativa:

The recommended initial dose is 160 mg, followed by 80 mg two weeks later. The first dose of 160 mg can be administered as four injections in one day or as two injections per day for two consecutive days. The second dose of 80 mg is given as two 40 mg injections in one day.

The recommended maintenance dose regimen is 40 mg every week beginning four weeks after the initial dose.

Adults with Psoriasis or Uveitis:

The recommended dose is an initial dose of 80 mg, followed by 40 mg given every other week starting one week after the initial dose.

Children, 13 to 17 years of age weighing ≥ 40 kg, with Crohn’s disease:

The recommended dose is 160 mg initially at Week 0 (given as four 40 mg injections in one day, or as two 40 mg injections per day for two consecutive days), followed by 80 mg at Week 2 (given as two 40 mg injections). At Week 4, you will begin a maintenance dose of 20 mg every other week. Depending on your response, the doctor may increase the dose to 40 mg every other week (given as one 40 mg injection).

For children who do not require a full 40 mg dose of Hyrimoz, a 20 mg pre-filled syringe is also available.

Adolescents, 12 to 17 years of age weighing ≥ 30 kg, with Hidradenitis Suppurativa:

The recommended initial dose is 80 mg administered by subcutaneous injection, followed by 40 mg every other week starting one week later. Depending on your response, the doctor may increase the dose to 40 mg every week.

Children, from 2 years of age with Uveitis:

weighing less than 30 kg: the usual dose of Hyrimoz is 20 mg every other week with methotrexate. Your child’s doctor may also prescribe an initial dose of 40 mg to be administered one week prior to the start of the usual dose if your child is older than 6 years of age.
weighing 30 kg or more: the usual dose of Hyrimoz is 40 mg every other week with methotrexate. Your child’s doctor may also prescribe an initial dose of 80 mg to be
- administered one week prior to the start of the usual dose.

For children who do not require a full 40 mg dose of Hyrimoz, a 20 mg pre-filled syringe is also available.

Children, from 5 to 17 years of age with Ulcerative Colitis:

weighing less than 40 kg: the induction dose of Hyrimoz is 80 mg at Week 0, followed by 40 mg at Week 2. The recommended Hyrimoz maintenance dose regimen is 40 mg every other week or 20 mg every week beginning at Week 4.
weighing 40 kg or more: the induction dose of Hyrimoz is 160 mg at Week 0, followed by 80 mg at Week 2. The recommended Hyrimoz maintenance dose regimen is 80 mg every other week or 40 mg every week beginning at Week 4.
INSTRUCTION FOR USE
20 mg / 0.4 mL
Single-use Prefilled Syringe with Needle Guard and add-on finger flange

The following instructions explain how to inject Hyrimoz. Please read the instructions carefully and follow them step-by-step. You will be instructed by your doctor or assistant on the technique of injection. Do not attempt to inject until you are sure that you understand how to prepare and give the injection. After proper training, the injection can be self -administered or given by another person; for example, a healthcare professional, a family member or friend.

Figure A: Hyrimoz pre-filled syringe with BD UltraSafe Passive™ Needle Guard and add-on finger flange

What do you need for your injection?

Included in your Hyrimoz pre-filled syringe carton is:

a new Hyrimoz pre-filled syringe (see Figure A). Each pre-filled syringe contains 20 mg/0.4 mL of Hyrimoz.

Not included in you Hyrimoz pre-filled syringe carton

Alcohol swab
Cotton ball or gauze
Sharps disposal container

Figure B: items not included in the carton

See “4. Dispose of used Hyrimoz single-dose pre-filled syringes” at the end of this Instructions for Use.

Before your injection

Preparing the Hyrimoz single-dose pre-filled syringe

For a more comfortable injection, take the carton containing the Hyrimoz pre-filled syringe out of the refrigerator and leave it unopened on your work surface for about 15 to 30 minutes so that it reaches room temperature.
Wash your hands well with soap and water.
Clean the injection site with an alcohol swab
Remove the Hyrimoz pre-filled syringe from the outer carton and take it out of the blister.
Inspect the Hyrimoz pre-filled syringe. Look through the viewing window. The liquid should be clear, colorless or slightly yellowish and may contain small, translucent or white floating particles of protein. Do not use if any other particulates and/or discolorations are observed. If you are concerned with the appearance of the solution, then contact your pharmacist for assistance.
Do not use the Hyrimoz pre-filled syringe if it is broken or the needle guard is activated. Return the Hyrimoz pre-filled syringe and the package it came in to the pharmacy.
Look at the expiration date (EXP) on your Hyrimoz pre-filled syringe. Do not use your Hyrimoz pre-filled syringe if the expiration date has passed.
Choosing your injection site:
The recommended injection site is the front of your thighs. You may also use the lower abdomen, but not the area 2 inches (5 cm) around your navel (belly button) (see Figure C).
Choose a different site each time you give yourself an injection.
Do not inject into areas where the skin is tender, bruised, red, scaly, or hard. Avoid areas with scars or stretch marks. If you have psoriasis, you should NOT inject directly into areas with psoriasis plaques.

Figure C: choose your injection site

2.
Cleaning your injection site:
- Using a circular motion, clean the injection site with an alcohol wipe. Leave it to dry before injecting (see Figure D).
- Do not touch the cleaned area before injecting

Figure D: clean your injection site

3. Giving your injection

Figure E: needle guard is not activated – the single-dose pre-filled Hyrimoz is ready for use

In this configuration the needle guard is NOT ACTIVATED.
The Hyrimoz pre-filled syringe is ready for use (see Figure E).

Figure F: needle guard is activated – do not use

In this configuration the needle guard of your Hyrimoz pre-filled syringe is ACTIVATED.
DO NOT USE the pre-filled syringe (see figure F).
Carefully pull the needle cap straight off to remove it from the single-dose pre-filled Hyrimoz syringe (see Figure G).
Discard the needle cap.
You may see a drop of liquid at the end of the needle. This is normal.

Figure G: pull the needle cap off

Gently pinch the skin at the injection site (see Figure H).
Insert the needle into your skin as shown.
Push the needle all the way in to ensure that the medication can be fully administered

Figure H: insert the needle

Hold the single-dose pre-filled Hyrimoz syringe as shown (see Figure I).
Slowly press down on the plunger as far as it will go, so that the plunger head is completely between the needle guard wings.
Continue to press fully on the plunger for an additional 5 seconds. Hold the syringe in place for 5 seconds

Figure I: hold the syringe

Keep the plunger fully pressed down while you carefully lift the needle straight out
- from the injection site and let go off your skin (see Figure J).

Figure J: lift the needle straight out

Slowly release the plunger and allow the needle safety guard to automatically cover the exposed needle (see Figure K).
There may be a small amount of blood at the injection site. You can press a cotton ball or gauze onto the injection site and hold it for 10 seconds. Do not rub the injection site. You may cover the injection site with a small adhesive bandage, if needed

Figure K: slowly release the plunger

4.
Disposing of used single-dose pre-filled Hyrimoz syringes
- Dispose of the used pens in a sharps container (closable, puncture-resistant container). For the safety and health of you and others, the pens must never be re-used.
- Do not throw away any medicines via wastewater or household waste. Ask your doctor or pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. Any unused product or waste material should be disposed of in accordance with local requirements.

Figure L: dispose of your used pre-filled syringe

Overdose:

If you accidentally inject Hyrimoz more frequently than instructed, contact your doctor or local poison control centre right away.

If you think you have taken too much Hyrimoz, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.

Missed Dose:

If you forget to give yourself an injection, you should inject the missed dose of Hyrimoz as soon as you remember. Then administer the next dose as you would have on the originally scheduled date.

What are possible side effects from using Hyrimoz?

These are not all the possible side effects you may feel when taking Hyrimoz. If you experience any side effects not listed here, contact your healthcare professional.

Like all medicines, Hyrimoz can cause side effects. Most side effects are mild to moderate. However, some may be serious and require treatment.

Tell your doctor immediately if you experience any of the following:

severe rash, hives or other signs of allergic reaction
swollen face, hands, feet
trouble breathing, swallowing
sudden weight gain; this is possibly indicative of new or worsening heart failure
bruising or bleeding very easily, looking very pale; this could mean a blood problem such as low red blood cells (anemia) or low platelets.

Tell the doctor as soon as possible if you notice any of the following:

signs of infection such as fever, malaise, wounds, dental problems, burning on urination
feeling weak or tired
coughing
tingling
numbness
double vision
arm or leg weakness
arm or leg pain, swelling or redness
bump or open sore that does not heal
red scaly patches or raised bumps that are filled with pus; this could be new or worsening hidradenitis suppurativa, new or worsening psoriasis or a skin infection
alopecia (loss of hair)
changes in the colour of the skin
changes in the colour of your urine (dark or red)
worsening of the appearance of a scar
night sweats
weight loss
pain in the abdomen or chest

Serious side effects and what to do about them

Symptom / effect	Talk to your healthcare professional	Stop taking drug and get immediate medical help
Only if severe	In all cases
VERY COMMON Injection site reaction		✓
COMMON Cough and cold symptoms, including sore throat		✓
Headache	✓
Rash		✓
Nausea		✓
Pneumonia		✓	✓
Fever		✓
Abdominal pain	✓
UNCOMMON Tuberculosis		✓	✓
Other serious infections		✓	✓
Nerve disorder		✓	✓
Appendicitis		✓	✓
Blood clots: abdominal pain, chest pain, leg or arm pain with redness and swelling		✓	✓
Bladder infection (painful urination)		✓	✓
Hepatitis (jaundice [yellow skin, dark urine], abdominal pain, tiredness)		✓	✓

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

Visiting the Web page on Adverse Reaction Reporting (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php) for information on how to report online, by mail or by fax; or
Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Keep Hyrimoz and all other medicines out of the reach of children.

Store between 2 and 8ºC (in a refrigerator) in the original carton until ready to use. Do not freeze your Hyrimoz pre-filled syringes. DO NOT FREEZE Hyrimoz. Do not store your Hyrimoz pre-filled syringes in extreme heat or cold. Protect from light. Refrigerated Hyrimoz remains stable until the expiration date printed on the pre-filled syringe. Do not use beyond the expiration date.

When needed, for example when you are travelling, a Hyrimoz pre-filled syringe can be stored at room temperature (up to 25ºC/77ºF) for a single maximum period of 21 days.

Once taken out of the refrigerator for room temperature storage, a Hyrimoz pre-filled syringe must be used within 21 days, even if it is put back in the refrigerator. If not used within 21 days, the Hyrimoz pre-filled syringe must be discarded. You should record the date when the Hyrimoz pre-filled syringe is first removed from the refrigerator.

Care should be taken to avoid dropping or crushing the product as it contains a glass syringe.

General Advice About Prescription Medicines

Talk to your doctor or other healthcare provider if you have any questions about this medicine or your condition. Medicines are sometimes prescribed for purposes other than those listed in a PATIENT MEDICATION INFORMATION leaflet. If you have any concerns about this medicine, ask the doctor. The doctor or pharmacist can give you information about this medicine that was written for healthcare professionals. Do not use this medicine for a condition for which it was not prescribed. Do not share this medicine with other people.

Keep Hyrimoz and all medicines out of the reach of children.

If you want more information about Hyrimoz:

Talk to your healthcare professional
Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (http://hc-sc.gc.ca/index-eng.php); the manufacturer’s website www.sandoz.ca, or by calling 1-800-361-3062.

Last Revised October 31, 2023

INSTRUCTION FOR USE

40 mg / 0.8 mL

Single-use Pre-filled SensoReady^®Pen

The following instructions explain how to inject Hyrimoz. Please read the instructions carefully and follow them step-by-step. You will be instructed by your doctor or assistant on the technique of injection. Do not attempt to inject until you are sure that you understand how to prepare and give the injection. After proper training, the injection can be self-administered or given by another person; for example, a healthcare professional, a family member or friend.