Details for: YUFLYMA
Company: CELLTRION HEALTHCARE CO LTD
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02523779 | YUFLYMA | ADALIMUMAB | 40 MG / 0.4 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
See the Instructions For Use.
What it does
See the Instructions For Use
When it should not be used
You/Your child have
- hypersensitivity to YuflymaTM (adalimumab) or any of its components.
- severe infections such as sepsis, tuberculosis and opportunistic infections.
- moderate to severe heart failure (NYHA class III/IV).
What the medicinal ingredient is
Medicinal ingredients: adalimumab
What the non-medicinal ingredients are
Non-medicinal ingredients: acetic acid, glycine, polysorbate 80, sodium acetate trihydrate, and water for injection
What dosage form it comes in
YuflymaTM (adalimumab injection) is supplied as a sterile solution for subcutaneous administration(40 mg/ 0.4 ml).
Warnings and precautions
Serious Warnings and Precautions
Hepatosplenic T-Cell Lymphoma
Very rare post-marketing reports of hepatosplenic T-cell lymphoma (HSTCL), a rare aggressive lymphoma that is often fatal, have been identified in patients treated with adalimumab injection. Most of the patients had prior infliximab therapy as well as concomitant azathioprine or 6- mercaptopurine use for Crohn’s disease. The potential risk with the combination of azathioprine or 6-mercaptopurine and adalimumab injection should be carefully considered. The causal association of HSTCL with adalimumab injection is not clear.
Infections
Serious infections due to bacterial, mycobacterial, invasive fungal (disseminated or extrapulmonary histoplasmosis, aspergillosis, coccidiodomycosis), viral, parasitic, or other opportunistic infections have been reported in patients receiving tumor necrosis factor (TNF)- blocking agents. Sepsis, rare cases of tuberculosis, candidiasis, listeriosis, legionellosis and pneumocystis have also been reported with the use of TNF-blocking agents, including adalimumab injection. Other serious infections seen in clinical trials include pneumonia, pyelonephritis, septic arthritis and septicemia. Hospitalization or fatal outcomes associated with infections have been reported. Many of the serious infections have occurred in patients on concomitant immunosuppressive therapy that, in addition to their underlying disease, could predispose them to infections. Treatment with YuflymaTM should not be initiated in patients with active infections, including chronic or localized infections, until infections are controlled. In patients who have been exposed to tuberculosis, and patients who have travelled in areas of high risk of tuberculosis or endemic mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis, the risk and benefits of treatment with YuflymaTM should be considered prior to initiating therapy.
See (WARNINGS AND PRECAUTIONS, Infections, Other Opportunistic Infections).
As with other TNF-blockers, patients should be monitored closely for infections (including tuberculosis) before, during and after treatment with YuflymaTM. Patients who develop a new infection while undergoing treatment with YuflymaTM should be monitored closely and undergo a complete diagnostic evaluation. Administration of YuflymaTM should be discontinued if a patient develops a serious infection or sepsis, and appropriate antimicrobial or antifungal therapy should be initiated. Physicians should exercise caution when considering the use of YuflymaTM in patients with a history of recurrent infection or with underlying conditions which may predispose them to infections, or patients who have resided in regions where tuberculosis and histoplasmosis are endemic. See (WARNINGS AND PRECAUTIONS, Infections, Tuberculosis) and (ADVERSE REACTIONS, Adverse Drug Reaction Overview, Infections). The benefits and risks of treatment with YuflymaTM should be carefully considered before initiating therapy.
Pediatric Malignancy
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF-blockers, including adalimumab injection.
See (WARNINGS AND PRECAUTIONS, Malignancies, Malignancies in Pediatric Patients and Young Adults).
- you/your child have or have had any kind of infection including an infection that is in only one place in your/your child’s body (such as an open cut or sore), or an infection that is in your/your child’s whole body (such as the flu). Having an infection could put you/your child at risk for serious side effects from YuflymaTM. If you are unsure, ask your/your child’s doctor.
- you/your child have a history of infections that keep coming back or other conditions that might increase your/your child’s risk of infections, including fungal infections.
- you/your child have ever had tuberculosis, or if you/your child have been in close contact with someone who has had tuberculosis. If you/your child develop any of the symptoms of tuberculosis (a dry cough that doesn't go away, weight loss, fever, night sweats) call your/your child’s doctor right away. Your/your child’s doctor will need to examine you/your child for tuberculosis and perform a skin test.
- you/your child 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/your child’s body. If you/your child take YuflymaTM these may become active or more severe. If you don’t know if you/your child have lived in or travelled to an area where these infections are common, ask your/your child’s doctor.
- you/your child 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-colored urine, vomiting, and abdominal pain. If you/your child experience any of these signs and symptoms, contact your/your child’s doctor immediately. These symptoms may occur several months after starting therapy with YuflymaTM.
- you/your child experience any numbness or tingling or have ever had a disease that affects your/your child’s nervous system like multiple sclerosis or Guillain-Barré syndrome.
- you/your child have or have had heart failure.
- you/your child are scheduled to have major surgery or dental procedures.
- you/your child 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 YuflymaTM.
- you/your child are taking other medicines for your/your child’s rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, psoriasis, or other conditions. You/your child can take other medicines provided your/your child’s doctor has prescribed them or has told you/your child it is acceptable that you/your child take them while you/your child are taking YuflymaTM. It is important that you tell your/your child’s doctor about any other medicines you/your child are taking for other conditions (for example, high blood pressure medicine) before you/your child start taking YuflymaTM.
- you/your child are taking any over-the-counter drugs, herbal medicines and vitamin and mineral supplements.
- you/your child are pregnant or could become pregnant
- you/your child are breast-feeding or plan to breast-feed.
Interactions with this medication
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 Yuflyma:
- other TNF-blockers such as Enbrel®, Remicade®, Cimzia®, or Simponi®
- abatacept (Orencia®)
- anakinra (Kineret®)
Proper use of this medication
YuflymaTM is administered by injection under the skin (by subcutaneous injection).
See the Instructions For Use.
Usual Dose:
Adults with Rheumatoid Arthritis, Psoriatic Arthritis or Ankylosing Spondylitis:
- The recommended dose is 40 mg administered every other week as a subcutaneous injection.
Patients with polyarticular juvenile idiopathic arthritis:
- Weighing 30 kg or more: the recommended dose of YuflymaTM is 40 mg subcutaneously every other week.
- Yuflyma is only available for children who require the full 40 mg dosage. The pre-filled syringe and pre-filled pen are not designed to deliver less than the full 40 mg dose.
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 subcutaneously given every other week starting one week after the initial dose.
Pediatric Uveitis:
- The recommended dose is an initial dose of 80 mg, followed by 40 mg subcutaneously given every other week starting one week after the initial dose.
- Yuflyma is only available for children who require the full 40 mg dosage. The pre-filled syringe and pre-filled pen are not designed to deliver less than the full 40 mg 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).
Overdose:
If you/your child accidentally inject YuflymaTM more frequently than instructed, contact your/your child’s doctor or local poison control centre right away.
Missed Dose
If you/your child forget to give yourself/your child an injection, you/your child should inject the missed dose of YuflymaTM as soon as you/your child remember. Then administer the next dose as you/your child would have on the originally scheduled date.
Side effects and what to do about them
These are not all the possible side effects you/your child may feel when taking YuflymaTM. If you/your child experience any side effects not listed here, contact your/your child’s healthcare professional. Please also see Warnings and Precautions.
Like all medicines, YuflymaTM can cause side effects. Most side effects are mild to moderate. However, some may be serious and require treatment.
Tell your/your child’s doctor immediately if you/your child 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/your child 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/your child’s urine (dark or red)
- worsening of the appearance of a scar
- night sweats
- weight loss
- pain in the abdomen or chest
| 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 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/your child have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your/your child’s daily activities, talk to your/your child’s healthcare professional.
How to store
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 (https://www.canada.ca/en/healthcanada/services/drugs-health-products/medeffect-canada.html) 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
If you want more information about Yuflyma
- 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: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drugproduct-database.html; the manufacturer’s website [website], or by calling 1-800-[phone number].