Temziva (Tocilizumab) for Treatment of Inflammatory Diseases

Temziva contains the active substance tocilizumab, which is a protein made from specific immune cells, that blocks the action of a specific protein (cytokine) called interleukin-6. IL-6 activity in the body causes inflammation in the body. Temzia Blocks the IL-6 receptors and reduces the inflammation in your body and reduces symptoms.

• Treat adults with moderate to severe active rheumatoid arthritis (RA). Temziva can be given alone or in combination with Methotrexate and other non-biologic DMARDs.

• Treat active Polyarticular Juvenile Idiopathic Arthritis (pJIA) in children aged 2 years and over. Temziva can be given alone or in combination with Methotrexate.

• Treat Cytokine Release Syndrome (CRS) in adults and children aged 2 years and over. CRS is a side-effect in patients treated with chimeric antigen receptor (CAR) T-cell therapies used to treat certain types of cancer.

• Treat active Systemic Juvenile Idiopathic Arthritis (sJIA) in children aged 2 years and over. Temziva can be given alone or in combination with methotrexate and other DMARDs.

• Treat Cytokine Release Syndrome in patients with a definite diagnosis of COVID-19.

• You are allergic to tocilizumab or any of the other ingredients of this medicine.

• You have an active, severe infection.

• Temziva is not recommended in children under 2 years of age.

What should I tell my doctor before using Temzia?

• Are being treated for infection, have an infection, or have symptoms of an infection.

• If you have or had tuberculosis (TB), you should inform your doctor. Patients with latent TB should be treated before initiating Temziva. Your doctor will check the signs and symptoms of tuberculosis before starting Temziva. If symptoms of tuberculosis (weight loss, listlessness, persistent cough, mild fever) appear during or after treatment, tell your doctor immediately.

• If you have or have had hepatitis B.

• If you have or had had intestinal ulcers or diverticulitis. If you have symptoms such as; abdominal pain, hemorrhage, and unexplained changes in bowel habits with the fever, call your doctor as it may be a sign of diverticulitis.

• If you have or had liver disease, inform your doctor. Temziva can increase the liver enzymes (particularly when administered concomitantly with MTX) therefore, a blood test should be done to evaluate the liver function before starting treatment with Temziva.

• A complete blood count should be performed before starting treatment with Temziva in order to make sure that you have normal levels of neutrophils, white blood cells, and platelets. Treatment with Temziva should not be initiated in people who have low levels of neutrophils, white blood cells, and platelets.

• If you have a high blood level of cholesterol or triglycerides or previous history of it, you should inform your doctor. Measurement of lipid parameters should be performed before and also, 4 to 8 weeks after administration of Temziva. Temziva can disturb lipid profile by increasing the level of these parameters. In this case, patients should use the appropriate drugs to regulate their lipid profile.

• If you or your close relative have a history of central nervous system disease (CNS) such as MS, inform your doctor, because there are some reports that demonstrate the relation between Temziva and CNS disorders.

• If you have recently been vaccinated or are planning a vaccination. Live vaccines should not be given concurrently with Temziva.

• If you have cancer.

• If you have cardiovascular risk factors such as increased blood pressure or cholesterol levels. These factors need to be monitored while receiving Temziva.

• If you have moderate to severe kidney function problems, your doctor will monitor you.

• If you have severe persistent headaches.

• Are pregnant or planning to become pregnant. It is unknown if Temziva can harm your unborn baby. Women must use effective contraception during and up to 3 months after treatment. Tell your doctor if you become pregnant during treatment or in less than 3 months of discontinuation.

• It is not known whether Temziva is passed into breast milk

Tell your doctor if you are taking or have recently taken any medicines even herbal, vitamins, or OTC.

Temziva can affect the way some medicines work, and the dose of these may require adjustment. If you are using medicines containing any of the following active substances, tell your doctor:

• Simvastatin or atorvastatin, used to reduce cholesterol levels.

• Methylprednisolone, dexamethasone, used to reduce inflammation.

• Theophylline, used to treat asthma.

• Calcium channel blockers (e.g. amlodipine), used to treat raised blood pressure.

• Warfarin or phenprocoumon, used as blood thinning agents.

• Phenytoin, used to treat convulsions.

• Benzodiazepines, used to relieve anxiety.

• Ciclosporin, used to suppress your immune system during organ transplants.

Due to a lack of clinical experience, Temziva is not recommended for use with other biological medicines for the treatment of RA, sJIA, or pJIA.

Temziva can cause dizziness. If you feel dizzy, do not drive or use machines.

The usual dose of Temziva is 8 mg per kg of body weight, once every four weeks. For individuals whose body weight is more than 100 kg, doses exceeding 800 mg per infusion are not recommended. Temziva is given through a drip in the vein (intravenous infusion) over one hour.

• If the patient weighs less than 30 kg: the dose is 12 mg for every kilogram of body weight.

• If the patient weighs 30 kg or more: the dose is 8 mg for every kilogram of body weight.

• Children with sJIA will be given Temziva once every 2 weeks through a drip in the vein (intravenous infusion) over one hour.

• If the patient weighs less than 30 kg: the dose is 10mg for every kilogram of body weight.

• If the patient weighs 30 kg or more: the dose is 8 mg for every kilogram of body weight.

• Cytokine Release Syndrome (CRS): The usual dose of Temziva is 8 mg for every kg of body weight if the patient weighs 30 kg or more. The dose is 12 mg for every kg of body weight if the patient weighs less than 30 kg. Temziva can be given alone or in combination with corticosteroids.

• Children with pJIA: will be given Temziva once every 4 weeks through a drip in the vein (intravenous infusion) over one hour.

• Elderly: No dose adjustment is required in elderly patients >65 years of age.

• Renal impairment: No dose adjustment is required in patients with mild renal impairment. Temziva has not been studied in patients with moderate to severe renal impairment. Renal function should be monitored closely in these patients.

• Hepatic impairment: Temziva has not been studied in patients with hepatic impairment. Therefore, no dose recommendations can be made.

• Recommended dose in children and infants: Temziva is not recommended under age 2.

• Method of administration: Temziva is given through a drip in the vein (intravenous infusion) over one hour.

Tocilizumab can cause serious side effects. In this case, for performing the best therapeutic actions,
you should contact your doctor immediately.

• Serious Infection: Temziva can serious infections and may even make them worse. Temziva should not be given to patients with active infections and using Temziva should be stopped if a serious infection occurs during using Temziva. You should inform your doctor immediately if you have the symptoms of infection such as fever, lethargy, Influenza, chills, mouth or skin blister, and stomach ache.

• Allergic reactions during or after infusion: If you experience allergic reactions such as severe dizziness or light-headedness, chest tightness, wheezing, swelling of the lips, or skin rash during treatment with Temziva, you should call your doctor immediately. If such allergic reactions occur, using of Temziva should be stopped immediately and appropriate treatment should be done to reduce the allergy. Also, Temziva should be discontinued permanently.

• Liver Toxicity: signs and symptoms of liver toxicity are tiredness, abdominal pain, and jaundice (yellow discoloration of skin or eyes).

• rash, itching, hives, swelling of the lips, tongue, or face

• Upper respiratory tract infections with typical symptoms such as cough, blocked nose, runny nose, sore throat, and headache

• high blood fat (cholesterol) levels.

• headache

• dizziness

• cough

• shortness of breath

• stomach pain

• mouth ulcers

• rash and itching, hives

• allergic (hypersensitivity) reactions

• fluid retention (oedema) in the lower legs

• high blood pressure

• abnormal liver function (abnormal liver function tests)

• weight increase

• increased bilirubin

• eye infection (conjunctivitis)

• low white blood cell counts shown by blood tests (neutropenia, leucopenia)

• low fibrinogen levels in the blood

• lung infection (pneumonia)

• shingles (herpes zoster)

• cold sores (oral herpes simplex), blisters

• hypothyroidism

• red swollen areas in the mouth

• stomach ulcer

• diverticulitis (fever, nausea, diarrhea, constipation, stomach pain)

• high blood fat (triglycerides)

• kidney stones

• Stevens-Johnson syndrome (skin rash, which may lead to severe blistering and peeling of the skin)

• Fatal Allergic Reactions (Anaphylaxis)

• inflammation of the liver (hepatitis)

• jaundice.

• low counts for white blood cells, red blood cells and platelets in blood tests

• liver failure.

• Keep Temziva out of reach of children.

• Store in a refrigerator (2°C – 8°C).

• Do not freeze.

• Keep the vial in the outer carton in order to protect it from light.

The active substance is tocilizumab.
The inactive ingredients are sucrose, polysorbate 80, disodium phosphate dodecahydrate, sodium
dihydrogen phosphate dihydrate, and water for injections.