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Actemra (Generic Tocilizumab Injection)

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WARNING

Using tocilizumab injection may reduce your body’s capacity to fight against bacterial, viral, and fungal infections and raise your chance of developing a serious or potentially fatal illness that can spread throughout the body. Inform your doctor if you frequently contract any kind of infection, currently possess one, or suspect one. This includes transient infections (like cold sores), minor infections (such open cuts or sores), and persistent infections that never go away. Additionally, let your doctor know if you have ever had diabetes, HIV, or any other immune-system-affecting conditions, as well as if you currently live in or have ever travelled to regions like the Southwest, the Ohio and Mississippi River valleys, or any other regions where severe fungal infections are more prevalent. If you are unsure whether these infections are widespread in your area, consult your doctor. You should also let your doctor know if you’re taking any of the following drugs: infliximab (Remicade), etanercept (Enbrel), golimumab (Simponi), certolizumab (Cimzia), abatacept (Orencia), adalimumab (Humira), anakinra (Kineret), adalimumab (Humira), methotre (Rituxan). Make a quick call to your doctor if you encounter any of the following signs: Fever, chills, sweating, breathing issues, sore throat, coughing, weight loss, diarrhoea, stomach discomfort, blood in phlegm, excessive fatigue, muscular pains, warm, red, or painful skin, sores on the body or in the mouth, burning when you urinate, frequent urination, or other infection-related symptoms.

You might have TB (a sort of lung infection) or hepatitis B (a type of liver illness), even though you don’t exhibit any symptoms. In this situation, tocilizumab injection may raise your risk of developing symptoms and a more serious illness. Your doctor may request blood tests to determine whether you have an inactive hepatitis B infection in addition to performing a skin test to determine whether you have a TB infection. Before you begin taking tocilizumab injection, your doctor may prescribe you medication to treat this infection, if necessary. Inform your doctor if you have or have ever had tuberculosis (TB), hepatitis B, travelled to any country where TB is prevalent, or have come into contact with someone who has TB. Call your doctor right away if you experience any of the following TB symptoms, or if any of them arise during your treatment: a cough, chest pain, coughing up blood or mucus, weakness or exhaustion, weight loss, lack of appetite, chills, fever, or night sweats. Call your doctor right once if you experience any of the following hepatitis B symptoms, or if any of these symptoms appear during or after treatment: Excessive fatigue, yellowing of the skin or eyes, loss of appetite, nausea, vomiting, headaches, dark urine, clay-colored bowel movements, fever, chills, stomach discomfort, or rash are some symptoms to watch out for.

Keep all of your appointments with your physician and the lab. In order to ensure that you do not acquire a major infection, your doctor will carefully check your health. Before and during your therapy, your doctor will order specific lab tests to monitor your body’s reaction to the tocilizumab injection.

When you start receiving tocilizumab injection for treatment and each time you receive the drug, your doctor or pharmacist will provide you the manufacturer’s patient information leaflet (Medication Guide). If you have any questions, carefully read the material and contact your doctor or pharmacist. The Medication Guide is also available on the manufacturer’s website or the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm).

Discuss the dangers of using tocilizumab injection with your doctor.

Why is this medication prescribed?

Tocilizumab injection is used either by itself or in conjunction with other drugs to treat a variety of illnesses, such as:

  • Adults with rheumatoid arthritis who have not found relief from other disease-modifying antirheumatic medications (a condition in which the body attacks its own joints, producing pain, swelling, and loss of function) (DMARDs),
  • Adults with giant cell arteritis, a disorder that causes blood vessels to enlarge, particularly in the scalp and skull,
  • Adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD; also known as scleroderma-associated ILD: a lung condition characterised by lung scarring),
  • Children 2 years of age and older who have polyarticular juvenile idiopathic arthritis (PJIA), a kind of paediatric arthritis that affects five or more joints during the first six months of the condition, may experience pain, swelling, and loss of function.
  • Children 2 years of age and older who have systemic juvenile idiopathic arthritis (SJIA), a disorder that causes inflammation in various parts of the body, might have fever, joint discomfort and swelling, loss of function, and delays in growth and development.
  • After receiving specific immunotherapy infusions, adults and children 2 years of age and older may experience cytokine release syndrome, a severe and sometimes fatal reaction.

The drug tocilizumab injection belongs to the group of drugs known as interleukin-6 (IL-6) receptor inhibitors. It functions by preventing the body’s interleukin-6, a chemical that triggers inflammation, from acting.

How should this medicine be used?

A doctor or nurse can administer tocilizumab injection intravenously (into a vein) over the course of roughly an hour in a doctor’s office or hospital outpatient clinic, or you can administer it yourself at home using a prefilled syringe just under the skin.

Tocilizumab is often administered intravenously once every four weeks, or subcutaneously once every week or every other week, to treat rheumatoid arthritis.

Tocilizumab is often administered subcutaneously once per week or every other week to treat giant cell arteritis.

Tocilizumab is typically administered subcutaneously once per week to treat interstitial lung disease associated with systemic sclerosis.

Tocilizumab is often administered intravenously once every 4 weeks or subcutaneously once every 2 or 3 weeks to treat polyarticular juvenile idiopathic arthritis.

Tocilizumab is often administered intravenously once every two weeks or subcutaneously once every week or once every two weeks to treat systemic juvenile idiopathic arthritis.

Tocilizumab is often administered intravenously to treat cytokine release syndrome. However, up to 3 further doses may be administered, each spaced at least 8 hours apart.

Your doctor’s office will administer your first tocilizumab injection subcutaneously. Your doctor will demonstrate how to inject tocilizumab injection subcutaneously if you plan to administer the drug yourself at home or have a friend or family member administer it on your behalf. The written directions for use that are provided with the drug should be read by both you and the person who will be injecting it.

You must take the tocilizumab injection out of the refrigerator, take it out of the box, and let it come to room temperature before you are ready to administer it. Be cautious not to contact the syringe’s trigger fingers when taking a prefilled syringe out of the package. The medication should not be warmed in any other ways, including the microwave, hot water, or any other manner.

The prefilled syringe’s cap should not be taken off while the medication is still heated. The cap shouldn’t be removed more than five minutes before administering the medication. After removing the cap, never put it back on. If you drop the syringe to the ground, do not use it.

Verify the prefilled syringe’s expiration date against the printed one on the package. Examine the liquid within the syringe while holding it with the covered needle pointed downward. The liquid shouldn’t be hazy, discoloured, or have lumps or particles in it; it should be clear or pale yellow. Do not inject the drug if there are any issues with the syringe or the container; instead, contact your pharmacist.

Except for the navel and the two inches around it, you can inject tocilizumab anyplace on your stomach or on the front of your thighs. The outer region of the upper arms may also be used if someone else is administering your prescription by injection. Skin that is painful, bruised, red, hard, or not unbroken, or that contains scars, moles, or bruises should not be injected with the drug. Every time you inject the drug, choose a different location at least an inch apart from the one you’ve previously used. Call your doctor or pharmacist if the entire dose is not administered.

Reusing or capping tocilizumab prefilled syringes after usage is not advised. Ask your pharmacist how to dispose of the container once you’ve disposed of any used syringes in it.

The injection of tocilizumab might help you manage your symptoms, but it won’t make your disease go away. Your doctor will closely monitor your progress to determine how effectively the tocilizumab injection is helping you. If there are certain changes in your laboratory findings, your doctor may change your dose or postpone your therapy. It is critical to communicate your feelings to your doctor during your therapy.

Other uses for this medicine

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before receiving tocilizumab injection,

  • If you have an allergy to tocilizumab, any other drugs, or any of the ingredients in tocilizumab injection, let your doctor and pharmacist know right once. For a list of the ingredients, consult the Medication Guide or speak with your pharmacist.
  • Inform your doctor and pharmacist about any additional prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products you are now taking or intend to use. Mention the drugs in the IMPORTANT WARNING section as well as any of the following: aspirin and other nonsteroidal anti-inflammatory medications (NSAIDs), such as ibuprofen (Advil, Motrin, others), and naproxen (Aleve, Naprosyn, others); anticoagulants (‘blood thinners’) such warfarin (Coumadin, Jantoven); oral contraceptives (birth control pills), statins like atorvastatin (Lipitor, in Caduet), lovastatin (Altoprev, in Advicor), and simvastatin (Zocor, in Vytorin), or theophylline (Elixophyllin, Theo-24, others). Your doctor might need to adjust your medication doses or keep a close eye out for any negative side effects. It’s important to inform your doctor about all of the medications you are taking, even ones that are not on this list, as many other drugs may also interact with tocilizumab injection.
  • Inform your doctor if you have or have ever had any of the following conditions: cancer, diverticulitis (small pouches in the lining of the large intestine that can become inflamed), ulcers in your stomach or intestines, high cholesterol and triglycerides, and any condition that affects the nervous system, such as multiple sclerosis (MS; a disease in which the nerves do not function properly and patients may experience weakness, numbness, loss of muscle coordination
  • If you are breastfeeding a child or intend to become pregnant, let your doctor know. Call your doctor if you fall pregnant while receiving tocilizumab injectable.
  • Inform the surgeon or dentist if you are undergoing surgery, including dental surgery, that you are receiving tocilizumab injection.
  • Before starting your tocilizumab injection treatment, ask your doctor if you need to have any shots. Before starting treatment, children should, whenever feasible, have all of their vaccines updated. Without consulting your doctor, avoid getting any immunisations while you are receiving therapy.

What special dietary instructions should I follow?

Keep eating normally unless your doctor instructs you otherwise.

What should I do if I forget a dose?

Call your doctor if you don’t show up for your tocilizumab infusion appointment.

Tocilizumab subcutaneous injections should be administered right away if a dosage is missed. If the next dose is soon due, skip the missed one and carry on with your regular dosing plan. To make up for a missing dose, do not provide a second injection. If you are unsure about when to administer a tocilizumab injection, contact your doctor or pharmacist.

What side effects can this medication cause?

Side effects from tocilizumab injection are possible. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Headache
  • Runny or itchy nose
  • Redness, itchiness, discomfort, or swelling where tocilizumab was applied may also occur.

Some adverse effects can be very harmful. Call your doctor right away or seek emergency medical attention if you develop any of these signs or any of the ones detailed in the IMPORTANT WARNING section:

  • Rash
  • Flushing
  • Itching
  • Swelling of the lower legs, hands, feet, ankles, lips, tongue, throat, arms, or other body parts
  • Breathing or swallowing challenges
  • Chest pain
  • Fainting or vertigo
  • Fever, persistent abdominal pain, or alteration in bowel habits
  • Yellow eyes or skin, right upper abdomen pain, unexplained bruising or bleeding, appetite loss, confusion, yellow or brown urine, or pale faeces are all symptoms that should be taken seriously.

The use of tocilizumab may make some types of cancer more likely to develop. You should discuss the dangers of using this drug with your doctor.

Other negative effects from tocilizumab injection are possible. If you have any strange side effects while taking this medicine, call your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication tightly closed, out of the reach of children, and in the original container in which it was supplied. Do not freeze tocilizumab injection; instead, keep it in the refrigerator. Prefilled syringes should be kept dry. Throw away any medication that has expired or is no longer required. Consult your pharmacist for advice on how to properly dispose of your medications.

As many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning. http://www.upandaway.org

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medicines website at http://goo.gl/c4Rm4p for additional information.

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at https://www.poisonhelp.org/help. Call emergency services right away if the person has collapsed, suffered a seizure, is having difficulty breathing, or cannot be roused.

What other information should I know?

Inquire about tocilizumab injection with your pharmacist if you have any questions.

Do not share your medication with anybody else. Any queries you may have regarding medication refills should be directed to your pharmacist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Actemra®
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