Tocilizumab-bavi (Intravenous)

Tocilizumab-bavi injection is used by itself or with other medicines to treat moderate to severe active rheumatoid arthritis in patients who have already tried other treatments that did not work well. This medicine is also used alone or with methotrexate to treat polyarticular juvenile idiopathic arthritis (PJIA) and systemic juvenile idiopathic arthritis (SJIA) in children 2 years of age and older.

This medicine should be given only by your doctor or under their direct supervision.

It is very important that your doctor checks you or your child's progress at regular visits to ensure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

You or your child will need to have a skin test for tuberculosis before starting this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis skin test.

Call your doctor right away if you or your child develop a cough that will not go away, weight loss, night sweats, fever, chills, or flu-like symptoms, including a runny or stuffy nose, headache, blurred vision, or feeling generally ill. These may be signs of an infection.

This medicine may cause serious stomach and bowel problems, especially if you have a history of ulcers or diverticulosis. Check with your doctor right away if you or your child experience severe stomach cramps or pain, black, tarry stools, diarrhea, fever, or severe and sometimes bloody vomiting while being treated with this medicine.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine will lower the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these issues, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers. Tell your doctor if you have any kind of infection before you start using this medicine. Also, inform your doctor if you have ever had an infection that would not go away or an infection that keeps coming back.

Using this medicine may increase your risk of certain cancers. Talk to your doctor if you experience unusual bleeding, bruising, weakness, swollen lymph nodes in the neck, underarms, or groin, or unexplained weight loss. Also, check with your doctor right away if your skin has red, scaly patches or raised bumps filled with pus.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you or your child have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.

While you or your child are being treated with tocilizumab-bavi, and after stopping treatment, it is important to see your doctor about the immunizations (vaccinations) you should receive. Do not get any immunizations (vaccines) without your doctor's approval. Tocilizumab-bavi may lower your body's resistance, and there is a chance you might get the infection the vaccine is meant to prevent. In addition, you should avoid being around others in your household who receive live virus vaccines because they could pass the virus on to you. Do not get close to them and do not stay in the same room with them for very long. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. If you have questions about this, talk to your doctor.

This medicine may increase the levels of cholesterol and fats in your blood. If this occurs, your doctor may prescribe medications to lower these levels. Talk to your doctor if you or your child have concerns.

Tocilizumab-bavi may cause headaches and skin reactions, including rash or itching, while you are receiving the injection or within 24 hours after receiving it. Check with your doctor or nurse right away if you or your child have any of these symptoms.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use this medicine, you and your doctor will need to weigh the risks against the benefits. Consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not shown any specific problems that would limit the usefulness of tocilizumab-bavi injection in children aged 2 years and older with PJIA and SJIA. However, safety and effectiveness have not been established for other conditions and in children younger than 2 years of age with PJIA and SJIA.

Geriatric

Studies have not shown any specific problems that would limit the usefulness of tocilizumab-bavi injection in elderly patients. However, older adults are more likely to have serious infections, which may require caution when using this medicine.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together, while others may be used together even if an interaction could occur. In these cases, your doctor may need to adjust the dose or take other precautions. When receiving this medicine, it is very important that your healthcare professional knows if you are taking any of the following medicines. The following interactions are based on their potential significance and are not a complete list.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or frequency of one or both medicines.

• Abatacept
• Abemaciclib
• Acalabrutinib
• Adenovirus Vaccine, Live
• Alfentanil
• Alosetron
• Anifrolumab-fnia
• Aprepitant
• Astemizole
• Atazanavir
• Atomoxetine
• Atorvastatin
• Avanafil
• Avapritinib
• Axitinib
• Bacillus of Calmette and Guerin Vaccine, Live
• Baricitinib
• Bosutinib
• Brigatinib
• Budesonide
• Buspirone
• Caffeine
• Celecoxib
• Ceritinib
• Cholera Vaccine, Live
• Cisapride
• Clobazam
• Cobimetinib
• Codeine
• Colchicine
• Conivaptan
• Crizotinib
• Cyclosporine
• Daridorexant
• Darifenacin
• Darunavir
• Dasatinib
• Dengue Tetravalent Vaccine, Live
• Desipramine
• Dexlansoprazole
• Dextromethorphan
• Diazepam
• Dihydroergotamine
• Docetaxel
• Dofetilide
• Doxepin
• Dronedarone
• Duloxetine
• Ebola Zaire Vaccine, Live
• Eletriptan
• Eliglustat
• Elvitegravir
• Encainide
• Entrectinib
• Eplerenone
• Ergotamine
• Everolimus
• Felodipine
• Fentanyl
• Fezolinetant
• Finerenone
• Flecainide
• Flibanserin
• Fluticasone
• Fosaprepitant
• Fosphenytoin
• Gliclazide
• Glipizide
• Glyburide
• Hexobarbital
• Ibrexafungerp
• Ibrutinib
• Ibuprofen
• Indinavir
• Infliximab
• Influenza Virus Vaccine, Live
• Isavuconazonium Sulfate
• Ivabradine
• Ivacaftor
• Ivosidenib
• Lansoprazole
• Levomethadyl
• Lomitapide
• Lopinavir
• Lornoxicam
• Lovastatin
• Lurasidone
• Maraviroc
• Measles Virus Vaccine, Live
• Melatonin
• Meloxicam
• Mephobarbital
• Metoprolol
• Mexiletine
• Midazolam
• Midostaurin
• Mobocertinib
• Mumps Virus Vaccine, Live
• Naloxegol
• Nebivolol
• Neratinib
• Nilotinib
• Nisoldipine
• Olaparib
• Omeprazole
• Oxycodone
• Pantoprazole
• Paritaprevir
• Paroxetine
• Pazopanib
• Perphenazine
• Phenytoin
• Pimavanserin
• Pimozide
• Piroxicam
• Poliovirus Vaccine, Live
• Pomalidomide
• Proguanil
• Propafenone
• Quetiapine
• Quinidine
• Quinine
• Rabeprazole
• Ramelteon
• Ribociclib
• Risperidone
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Ruxolitinib
• Selegiline
• Sildenafil
• Simvastatin
• Sirolimus
• Smallpox Monkeypox Vaccine, Live Non-Replicating
• Smallpox Vaccine
• Sonidegib
• Tacrine
• Tacrolimus
• Tamoxifen
• Tasimelteon
• Temsirolimus
• Theophylline
• Thioridazine
• Ticagrelor
• Tilidine
• Tipranavir
• Tizanidine
• Tolbutamide
• Tolterodine
• Tolvaptan
• Triazolam
• Trimipramine
• Typhoid Vaccine, Live
• Ubrogepant
• Ulipristal
• Vardenafil
• Varicella Virus Vaccine, Live
• Venetoclax
• Venlafaxine
• Voclosporin
• Yellow Fever Vaccine
• Yohimbine
• Zanubrutinib
• Zoster Vaccine, Live

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around mealtimes or with certain foods due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using this medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect how this medicine works. Make sure to inform your doctor if you have any other medical problems, especially:

• Chronic inflammatory demyelinating polyneuropathy (nerve problem) or
• Hyperlipidemia (high fats in the blood) or
• Liver disease, history of or
• Multiple sclerosis or
• Neutropenia (low level of white blood cells) or
• Stomach or bowel problems (e.g., diverticulitis, perforations, ulcers) or
• Thrombocytopenia (low number of platelets) or
• Weak immune system (e.g., HIV, cancer, or steroid use)—Use with caution. May worsen these conditions.

• Herpes zoster, history of or
• Tuberculosis, history of—Use with caution. May cause infections to reactivate.

• Infections (e.g., hepatitis B, bacteria, virus, fungus), active or recurring or
• Liver disease, active—Should not be used in patients with these conditions.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur, they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Blurred vision
• body aches or pain
• chills
• cough
• dizziness
• ear congestion
• fever
• headache
• loss of voice
• muscle aches
• nervousness
• pounding in the ears
• slow or fast heartbeat
• sneezing
• sore throat
• stuffy or runny nose
• trouble breathing
• unusual tiredness or weakness

Less common

• Black, tarry stools
• bloating or swelling of the face, arms, hands, lower legs, or feet
• chest pain or tightness
• constipation
• cough producing mucus
• depressed mood
• dry skin and hair
• feeling cold
• hair loss
• hoarseness or husky voice
• muscle cramps and stiffness
• painful or difficult urination
• rapid weight gain
• sores, ulcers, or white spots on the lips or in the mouth
• swollen glands
• tingling of the hands or feet
• unusual bleeding or bruising
• unusual weight gain or loss

Incidence not known

• Bleeding gums
• blistering, peeling, or loosening of the skin
• blood in the urine or stools
• clay-colored stools
• confusion
• coughing or spitting up blood
• dark urine
• diarrhea
• difficulty controlling your bladder or bowels
• difficulty swallowing
• difficulty walking
• fainting
• feeling sad
• forgetfulness
• hives, itching, skin rash
• indigestion
• itching, pain, redness, swelling, tenderness, or warmth on the skin
• joint or muscle pain
• lightheadedness
• loss of appetite
• lower back or side pain
• nausea
• night sweats
• numbness or tingling in your arms, legs, or face
• painful blisters on the trunk of your body
• pains in stomach, side, or abdomen, possibly radiating to the back
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red irritated eyes
• red skin lesions, often with a purple center
• slurred speech
• stomach pain or tenderness
• sudden high fever or low-grade fever for months
• unpleasant breath odor
• vomiting
• vomiting of blood
• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Facial swelling

Less common

• Burning, dry, or itching eyes
• eye discharge, excessive tearing
• irritation or soreness of the mouth
• redness, pain, swelling of eye, eyelid, or inner lining of the eyelid
• stomach bloating, burning, or cramping
• swelling or inflammation of the mouth

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Tofidence

Pharmacologic Class: Tocilizumab

Find detailed information on biosimilars for this medication.

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins. This medicine must be given slowly, so the IV will have to remain in place for 60 minutes.

This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

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