Tofidence (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 medicines that did not work well. This medicine is also used by itself 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 only be given by or under the direct supervision of your doctor.

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

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

Contact your doctor immediately if you or your child develop a cough that will not go away, experience weight loss, night sweats, fever, chills, or flu-like symptoms, such as a runny or stuffy nose, headache, blurred vision, or feeling generally unwell. 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. Consult your doctor right away if you or your child begin to have severe stomach cramps or pain, black or tarry stools, diarrhea, fever, or severe and sometimes bloody vomiting while on this medicine.

Consult your doctor immediately if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellowing of the 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 close contact with sick people. Wash your hands frequently. Stay away from rough sports or situations where you could get bruised, cut, or injured. Brush and floss your teeth gently. Be cautious when using sharp objects, including razors and fingernail clippers. Inform your doctor if you have any kind of infection before starting this medicine. Also, tell 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. Discuss with your doctor if you have unusual bleeding, bruising, or weakness, swollen lymph nodes in the neck, underarms, or groin, or unexplained weight loss. Additionally, contact your doctor immediately if you notice red, scaly patches on your skin, 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. Inform your doctor right away if you or your child experience 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 essential to consult your doctor regarding 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, increasing the chance of getting the infection that the vaccine is intended to prevent. Additionally, you should avoid close contact with anyone in your household who receives live virus vaccines, as they could potentially pass the virus to you. Do not stay in the same room with them for extended periods. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. If you have questions about this, consult your doctor.

This medicine may increase cholesterol and fat levels in your blood. If this occurs, your doctor may prescribe medications to lower these levels. Discuss any concerns with your doctor.

Tocilizumab-bavi may cause headaches and skin reactions, such as rash or itching, while you are receiving the injection or within 24 hours after receiving it. Contact your doctor or nurse immediately if you or your child experience any of these symptoms.

Do not take other medicines unless you have discussed them 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 weigh the risks against the benefits. The following factors should be considered:

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 allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Currently available studies have not shown any pediatric-specific problems that would limit the usefulness of tocilizumab-bavi injection in children 2 years of age 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 demonstrated geriatric-specific problems that would limit the usefulness of tocilizumab-bavi injection in older adults. However, older patients may be more likely to experience serious infections, which may require caution in patients taking this medicine.

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if there is a possibility of interaction. In these situations, your doctor may adjust the dose or take other precautions. When using this medicine, it is very important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions have been chosen based on their potential importance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is generally not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may modify 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 the time of eating certain foods, as interactions may happen. Drinking alcohol or using tobacco with some medicines can also lead to interactions. Talk to your healthcare professional about using this medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may impact the use of this medicine. Make sure to inform your doctor if you have any other medical issues, 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 required effects, this medicine may cause some unwanted effects. Not all side effects may occur, but if they do, you may need medical attention.

Check with your doctor or nurse right away if any of these side effects happen:

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. Your health care professional may also have ways to prevent or reduce some of these side effects. Check with your health care professional if any of these side effects continue, 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 happen in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You can 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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