Details for: ERELZI - 50 MG/ML
Company: SANDOZ CANADA INCORPORATED
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02462877 | ERELZI | ETANERCEPT | 25 MG / 0.5 ML | SOLUTION | SUBCUTANEOUS |
Summary Reports
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
Single-use Prefilled Syringe with Needle Guard
Single-use Prefilled SensoReady® Pen
Erelzi is a medicine for treating people with moderate to severe forms of rheumatoid arthritis (RA) or juvenile idiopathic arthritis (JIA). Erelzi is also for treating adults with a type of arthritis called ankylosing spondylitis (AS). RA, JIA, and AS are inflammatory diseases that affect the joints in your body.
What it does
Single-use Prefilled Syringe with Needle Guard
Single-use Prefilled SensoReady® Pen
Erelzi is a type of protein called a tumour necrosis factor (TNF) blocker that blocks the action of a substance your body makes called TNF-alpha. TNF-alpha is made by your body’s immune system. People with immune diseases like RA, JIA, as well as patients with AS, have too much TNF-alpha in their bodies, which can cause inflammation and lead to painful, swollen joints. Erelzi can reduce the amount of TNF in the body to normal levels, helping to treat joint damage. In patients with inflammatory arthritis, Erelzi may be effective in reducing signs and symptoms of inflammatory arthritis (such as pain, morning stiffness and fatigue), may help improve your ability to do simple daily activities (such as dressing, walking and climbing stairs), and may help prevent damage to your bones and joints.
When can I expect to see results from taking Erelzi?
Improvement may be seen as early as 1 week after starting etanercept in adults and within 2
weeks in children. In clinical trials, full effect was usually seen by 3 months in both adults and
children and was sustained with continued treatment.
When it should not be used
What the medicinal ingredient is
Single-use Prefilled Syringe with Needle Guard
Single-use Prefilled SensoReady® Pen
Medicinal ingredient: etanercept
What the non-medicinal ingredients are
Single-use Prefilled Syringe with Needle Guard
Single-use Prefilled SensoReady® Pen
Non-medicinal ingredients: citric acid, L-lysine hydrochloride, sodium chloride, sodium citrate and sucrose.
What dosage form it comes in
Erelzi Single-use Prefilled Syringes with Needle Guard are available in 25 mg (0.5 mL of a 50 mg/mL solution of etanercept) and 50 mg (1.0 mL of a 50 mg/mL solution of etanercept). Erelzi Single-use Prefilled SensoReady® Pens are available in 50 mg (1.0 mL of a 50 mg/mL solution of etanercept).
Warnings and precautions
Single-use Prefilled Syringe with Needle Guard
Single-use Prefilled SensoReady® Pen
Serious Warnings and Precautions
- Serious infections. There have been cases where patients taking etanercept or other TNF-blocking agents have developed serious infections, including tuberculosis (TB) and infections caused by bacteria, viruses or fungi that have spread throughout their body. Some patients have died from these infections. In very rare cases, hepatitis B recurred in patients with previous hepatitis. If you tend to get infections easily or if you develop an infection while taking etanercept, you should tell your doctor right away.
- Malignancies. There have been cases, sometimes fatal, of unusual cancers in children and teenage patients who started using TNF-blocking agents, including etanercept, at less than 18 years of age.
Do not use Erelzi if:
- You should not take Erelzi if you have ever had an allergic reaction to etanercept or any of the ingredients in Erelzi.
- You should not take Erelzi if you have an infection that has spread through your body (sepsis).
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Erelzi. Talk about any health conditions or problems you may have, including if you:
- have an infection. This could put you at risk for serious side effects from etanercept.
- have symptoms of an infection such as fever, sweats or chills, cough or flu-like symptoms, shortness of breath, blood in your phlegm, weight loss, muscle aches, warm, red, or painful areas on your skin, sores on your body, diarrhea or stomach pain, burning when you urinate or urinate more often than normal, and feel very tired.
- have a history of infections that keep coming back or other conditions ― like diabetes, HIV, or a weak immune system ― that might increase your risk of infections.
- have tuberculosis (TB), or have been in close contact with someone who has or has had TB. You will need to be evaluated for TB. Your doctor should test you for TB before starting etanercept.
- were born in, lived in, or traveled to countries where there is a risk for getting TB. Ask your doctor if you are not sure.
- live in, have lived in or have traveled to, areas where there is a greater risk for certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, blastomycosis). These infections may develop or become more severe if you take etanercept. If you don’t know if you have lived in an area where these infections are common, ask your doctor.
- have or have had hepatitis B.
- have or have had persistent numbness, tingling and muscle weakness or a disease such as multiple sclerosis, Guillain- Barré or a Guillain-Barré -like syndrome, which causes inflammation of the nervous system, either in the brain and spinal cord or nerves going to your hands and feet.
- have been newly diagnosed or are being treated for congestive heart failure.
- are scheduled to have major surgery.
- have recently received or are scheduled to receive a vaccine. All vaccines should be brought up-to-date before starting etanercept. Patients taking etanercept should not receive live vaccines.
- use the medication Kineret® (anakinra), Orencia®(abatacept) or cyclophosphamide (see INTERACTIONS WITH THIS MEDICATION below).
- have been around someone with varicella zoster (chicken pox, shingles)
Know the medicines you take. Keep a list of them to show your doctor and pharmacist each
time you get a new medicine.
Your doctor should monitor you closely for signs and symptoms of TB during treatment with
etanercept even if you have tested negative for TB. If you develop any of the symptoms of TB (a
dry cough that doesn’t go away, weight loss, fever, night sweats) call your doctor.
If you are not sure or have any questions about any of this information, ask your doctor.
Other warnings you should know about:
All medicines have side effects. Medicines, like Erelzi, that affect your immune system can cause serious side effects. The possible serious side effects include:
- Nervous system diseases. There have been rare cases of disorders that affect the nervous system of people taking etanercept or other TNF blockers, such as multiple sclerosis, seizures or inflammation of the nerves of the eyes. Signs that you could be experiencing a problem affecting your nervous system include: numbness or tingling throughout your body, problems with your vision, weakness in your arms and/or legs, and dizziness.
- Blood problems. In some patients the body may fail to produce enough of the blood cells that can help your body fight infections or help you to stop bleeding. This can lead to death. If you develop a fever that doesn’t go away, bruise or bleed very easily or look very pale or feel faint, call your doctor right away. Your doctor may decide to stop treatment. Some people have also had symptoms that resemble lupus (rash on your face and arms that gets worse in the sun) that may go away when you stop taking etanercept.
- Heart problems. You should also tell your doctor if you have ever been treated for heart failure. If you have, your doctor may choose not to start you on etanercept, or may want to monitor you more closely. Symptoms include shortness of breath or swelling of your ankles and feet.
- Allergic reactions. Some patients have had allergic reactions to etanercept. If you develop a severe rash, swollen face or difficulty breathing while taking etanercept, call your doctor right away.
- Malignancies. Patients with inflammatory diseases including RA or AS, particularly those with highly active disease, may be at higher risk for lymphoma (a type of cancer). For children and adults taking TNF-blocker medicines including etanercept, the chances of getting lymphoma or other cancers may increase. Whether treatment with etanercept might influence the development and course of malignancies in adults is unknown.
- Liver problems (autoimmune hepatitis). Liver problems can happen in people who use TNF blocker medicines, including etanercept. These problems can lead to liver failure and death. Call your doctor right away if you have any of these symptoms: feel very tired, skin or eyes look yellow, poor appetite or vomiting, pain on the right side of your stomach (abdomen). These symptoms may occur several months after starting and even after etanercept has been stopped.
- Serious infections. Etanercept can lower the ability of your immune system to fight infections. So, taking etanercept can make you more prone to getting infections or make any infection that you may have worse. Some people have serious infections while taking etanercept including infections that spread through the body such as tuberculosis (TB), legionellosis (usually a bacterial pneumonia), and listeriosis (usually from contaminated food). Other infections caused by viruses, fungi, bacteria or parasites may occur. Some people have died from these infections.
What are the common side effects?
In studies comparing etanercept to placebo (inactive injection), side effects that occurred more
frequently in patients treated with etanercept were:
- Reactions where the injection was given. These reactions are usually mild and include redness, swelling, itching, or bruising. These usually go away within 3 to 5 days. If you have pain, redness or swelling around the injection site that doesn’t go away or gets worse, call your doctor.
- Upper respiratory infections (sinus infections)
- Headaches
Can I take Erelzi if I am pregnant or breastfeeding?
Etanercept has not been studied in pregnant women or nursing mothers, therefore its effects on
pregnant women or nursing babies are not known.
You should tell your doctor if you are pregnant, become pregnant or are thinking about
becoming pregnant. If you took etanercept during pregnancy, talk to your doctor prior to
administration of live vaccines to your infant.
Etanercept can pass into breast milk. You and your doctor should decide if you will take
etanercept or breastfeed. You should not do both.
If you are not sure or have any questions about any of this information, ask your doctor.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
It is important that you tell your doctor about any other medicines (for example, high blood
pressure medicine) you are taking for other conditions before you start taking etanercept. You
should also tell your doctor about any over-the-counter drugs, herbal medicines and vitamin and
mineral supplements you are taking.
If you have diabetes and are taking medication to control your diabetes, your doctor may decide
you need less anti-diabetic medicine while taking etanercept.
Can I take Erelzi if I am taking other medicines for my RA, JIA, AS or other conditions?
In adults, Erelzi can be used in combination with methotrexate. However, little is known of the interaction of etanercept with methotrexate and other drugs in children with juvenile idiopathic arthritis.
Interactions with this medication
Single-use Prefilled Syringe with Needle Guard
Single-use Prefilled SensoReady® Pen
The following may interact with Erelzi:
- Taking etanercept with Kineret® (anakinra) is not recommended because this may increase your risk of getting a serious infection.
- Taking etanercept with Orencia® (abatacept) is not recommended because this may increase your risk for serious side effects.
- Taking etanercept with cyclophosphamide (used to treat cancer or immune diseases) is not recommended. You may have a higher chance for getting certain cancers when taking Erelzi with cyclophosphamide.
Proper use of this medication
Single-use Prefilled Syringe with Needle Guard
How to take Erelzi:
Usual Dose
Erelzi is given as an injection under the skin.
You may continue to use other medicines that help treat your condition while taking Erelzi, such
as non-steroidal anti-inflammatory drugs (NSAIDs) and prescription steroids, as recommended
by your doctor.
If you have RA or AS, the recommended dose of Erelzi for adults is 50 mg per week given as
one injection using a 50 mg single-use prefilled syringe or two injections using the 25 mg singleuse prefilled syringe.
Your doctor will tell you whether the two injections with the 25 mg singleuse prefilled syringe should be given on the same day once a week or on two different days (3
or 4 days apart) in the same week.
The recommended dose of Erelzi for children with juvenile idiopathic arthritis is based on the
child’s body weight. Your child’s doctor will tell you the correct amount of Erelzi your child
should take and will prescribe an appropriate strength of etanercept. Erelzi is available for
treatment of children and adolescents weighing 63 kg (138 pounds) or more.
Make sure you have been shown how to inject Erelzi before you do it yourself. Someone you
know can also help you with your injection. Remember to take this medicine just as your doctor
has told you and do not miss any doses.
Instructions for Use of the Erelzi pre-filled syringe
Read ALL the way through these instructions before injecting. It is important not to try to inject yourself until you have been trained by your doctor, nurse or pharmacist. The box contains Erelzi pre-filled syringe(s) individually sealed in a plastic blister.
After the medicine has been injected, the needle guard will be activated to cover the needle. This is intended to aid in the protection of healthcare professionals, patients who self-inject doctor-prescribed medicines and individuals who assist self-injecting patients from accidental needle stick injuries.
What you additionally need for your injection:
- Alcohol swab
- Cotton ball or gauze
- Sharps disposal container
Important Safety Information:
Caution: Keep the syringe out of the sight and reach of children.
1. Do not open the outer box until you are ready to use this medicine.
2. Do not use this medicine if the seal of the blister is broken, as it may not be safe for you to
use.
3. Do not shake the syringe.
4. Never leave the syringe lying around where others might tamper with it.
5. The pre-filled syringe has a needle guard that will be activated to cover the needle after the
injection is finished. The needle guard will help to prevent needle stick injuries to anyone
who handles the pre-filled syringe.
Be careful not to touch the needle guard wings before use. By touching them, the needle
guard may be activated too early.
6. Do not remove the needle cap until just before you give the injection.
7. The syringe cannot be re-used. Dispose of the used syringe immediately after use in a
sharps container.
Storage of the Erelzi pre-filled syringe
1. Store this medicine in its outer box to protect from light. Store in the refrigerator between
2°C to 8°C. DO NOT FREEZE.
2. Remember to take the blister out of the refrigerator and allow it to reach room temperature
before preparing it for injection (15–30 minutes).
3. Do not use the syringe after the expiry date which is stated on the outer box or syringe label
after “EXP”. If it has expired, return the entire pack to the pharmacy.
The Injection Site(s)
Preparing the Erelzi pre-filled syringe
1. Take the blister out of the refrigerator and leave it unopened for about 15–30 minutes so
that it reaches room temperature.
2. When you are ready to use the syringe, open the blister and wash your hands thoroughly
with soap and water.
3. Clean the injection site with an alcohol swab.
4. Take the syringe out of the blister.
5. Inspect the syringe. The liquid should be clear or slightly opalescent, colourless or slightly
yellowish, and may contain small white or almost translucent particles of protein. This
appearance is normal for Erelzi. DO NOT USE if the liquid is cloudy, discoloured, or has
large lumps, flakes, or coloured particles. DO NOT USE if the syringe is broken or the
needle safety guard is activated. In all these cases, return the entire product pack to the
pharmacy.
Single-use Prefilled SensoReady® Pen
Usual Dose
Erelzi is given as an injection under the skin.
You may continue to use other medicines that help treat your condition while taking Erelzi, such as non-steroidal anti-inflammatory drugs (NSAIDs) and prescription steroids, as recommended by your doctor.
If you have RA or AS, the recommended dose of Erelzi for adults is 50 mg per week given as one injection using a 50 mg single-use prefilled SensoReady® Pen.
The recommended dose of Erelzi for children with juvenile idiopathic arthritis is based on the child’s body weight. Your child’s doctor will tell you the correct amount of Erelzi your child should take and will prescribe an appropriate strength of etanercept. Erelzi is available for treatment of children and adolescents weighing 63 kg (138 pounds) or more.
Make sure you have been shown how to inject Erelzi before you do it yourself. Someone you know can also help you with your injection. Remember to take this medicine just as your doctor has told you and do not miss any doses.
Instructions for Use: Erelzi (etanercept) SensoReady® pen Solution for injection in a pre-filled pen
These instructions are to help you to inject correctly using the Erelzi SensoReady pen.
It is important not to try to inject yourself until you have been trained by your doctor, nurse or pharmacist.
Erelzi SensoReady® pen shown with the cap removed. Do not remove the cap until you are ready to inject.
Store your boxed pen in a refrigerator, between 2°C to 8°C and out of the reach of children.
- Do not freeze the pen.
- Do not shake the pen.
- Do not use the pen if it has been dropped with the cap removed.
For a more comfortable injection, take the pen out of the refrigerator 15-30 minutes before injecting to allow it to reach room temperature.
Overdose
Call your doctor if you accidentally inject Erelzi more frequently than instructed.
Missed Dose
If you forget to take Erelzi when you are supposed to, contact your doctor to find out when to take your next dose of Erelzi.
Side effects and what to do about them
These are not all the possible side effects you may feel when taking Erelzi. If you experience
any side effects not listed here, contact your healthcare professional. Please also see Warnings
and Precautions.
Like all medicines, Erelzi can cause side effects. Most side effects are mild to moderate.
However, some may be serious and require treatment.
Single-use Prefilled Syringe with Needle Guard
Single-use Prefilled SensoReady® Pen
| Symptom / effect | Talk to your healthcare professional only if severe | Talk to your healthcare professional in all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| VERY COMMON | |||
| Injection site reactions | ✔ | ||
| COMMON | |||
| Upper respiratory tract infections (sinus infections) | ✔ | ||
| Headaches | ✔ | ||
| Rare | |||
| Serious infections | ✔ | ✔ | |
| Tuberculosis | ✔ | ||
| Nerve disorders | ✔ | ||
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.
How to store
Single-use Prefilled Syringe with Needle Guard
Single-use Prefilled SensoReady® Pen
Erelzi should be refrigerated at 2°C to 8°C. Do NOT freeze Erelzi. Do not use Erelzi beyond the
expiration date stamped on the carton, blister or syringe label. DO NOT SHAKE. Store Erelzi in
the original carton to protect from light or physical damage.
For convenience, storage of individual syringes at room temperature between 20°C to 25°C for
a maximum single period of 28 days is permissible, with protection from light and sources of
heat. Once a syringe has been stored at room temperature, it should not be placed back into the
refrigerator. If not used within 28 days at room temperature, the syringe should be discarded.
Do not store Erelzi in extreme heat or cold. DO NOT FREEZE. Keep out of the reach of
children.
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 www.hc-sc.gc.ca/dhpmps/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.
More information
Read this carefully before you start taking Erelzi and each time you get a refill. This leaflet is a summary and will not tell you everything about this drug. Talk to your healthcare professional about your medical condition and treatment and ask if there is any new information about Erelzi. Erelzi is a biosimilar biologic drug (biosimilar) to the reference biologic drug Enbrel®. A biosimilar is authorized based on its similarity to a reference biologic drug that was already authorized for sale.
If you want more information about Erelzi:
- 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; the manufacturer’s website www.sandoz.ca, or by calling 1-800-361-3062.
This leaflet was prepared by Sandoz Canada Inc.
Last Revised MARCH-31-2017