Pronunciation:

toe-si-LIZ-oo-mab - bavi

Brand Names:

• Tofidence

Warnings:

Risk Of Serious InfectionsPatients treated with tocilizumab products including tocilizumab-bavi are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.If a serious infection develops, interrupt tocilizumab-bavi until the infection is controlled.Reported infections include: 1. Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients should be tested for latent tuberculosis before tocilizumab-bavi use and during therapy. Treatment for latent infection should be initiated prior to tocilizumab-bavi use. 2. Invasive fungal infections, including candidiasis, aspergillosis, and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease. 3. Bacterial, viral and other infections due to opportunistic pathogens.The risks and benefits of treatment with tocilizumab-bavi should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with tocilizumab-bavi, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy .

Classifications:

Pharmacologic—

Tocilizumab

Uses of This Medicine:

Tocilizumab-bavi injection is used alone or together with other medicines to treat moderate to severe active rheumatoid arthritis in patients who have been previously treated with other medicines but did not work well. This medicine is also used alone or together 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 is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional 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.

Children—

Appropriate studies performed to date have not demonstrated 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 efficacy have not been established for other conditions and in children younger than 2 years of age with PJIA and SJIA.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tocilizumab-bavi injection in the elderly. However, elderly patients are more likely to have serious infections, which may require caution in patients receiving this medicine.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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

• Abatacept
• Abemaciclib
• Acalabrutinib
• Adenovirus Vaccine, Live
• Alfentanil
• Anifrolumab-fnia
• Astemizole
• Axitinib
• Bacillus of Calmette and Guerin Vaccine, Live
• Baricitinib
• Bosutinib
• Brigatinib
• Ceritinib
• Cholera Vaccine, Live
• Cisapride
• Clindamycin
• Cobimetinib
• Colchicine
• Conivaptan
• Crizotinib
• Cyclosporine
• Dasatinib
• Dengue Tetravalent Vaccine, Live
• Desipramine
• Dihydroergotamine
• Docetaxel
• Dofetilide
• Dronedarone
• Ebola Zaire Vaccine, Live
• Entrectinib
• Ergotamine
• Everolimus
• Fentanyl
• Flecainide
• Flibanserin
• Fosphenytoin
• Glyburide
• Imipramine
• Infliximab
• Influenza Virus Vaccine, Live
• Ivosidenib
• Levomethadyl
• Lomitapide
• Measles Virus Vaccine, Live
• Mexiletine
• Midostaurin
• Mumps Virus Vaccine, Live
• Neratinib
• Nilotinib
• Nortriptyline
• Olaparib
• Oxycodone
• Paclitaxel
• Pazopanib
• Phenprocoumon
• Phenytoin
• Pimavanserin
• Pimozide
• Poliovirus Vaccine, Live
• Pomalidomide
• Quinidine
• Quinine
• Ribociclib
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Ruxolitinib
• Siponimod
• Sirolimus
• Smallpox Monkeypox Vaccine, Live Non-Replicating
• Smallpox Vaccine
• Sonidegib
• Sunitinib
• Tacrolimus
• Tamoxifen
• Temsirolimus
• Theophylline
• Thioridazine
• Tizanidine
• Tolbutamide
• Tolvaptan
• Trimipramine
• Typhoid Vaccine, Live
• Varicella Virus Vaccine, Live
• Warfarin
• Yellow Fever Vaccine
• Zanubrutinib
• Zoster Vaccine, Live

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell 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 (eg, diverticulitis, perforations, ulcers) or
• Thrombocytopenia (low number of platelets) or
• Weak immune system (eg, HIV, cancer, or steroid use)—Use with caution. May make these conditions worse.

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

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

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress at regular visits to make sure 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 you start using 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 start to have a cough that will not go away, weight loss, night sweats, fever, chills, or flu-like symptoms, including runny or stuffy nose, headache, blurred vision, or feeling generally ill. These may be signs that you have 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 start having severe stomach cramps or pain, black, tarry stools, diarrhea, fever, or vomiting that is severe and sometimes bloody 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 problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other 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 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 having certain cancers. Talk to your doctor if you have unusual bleeding, bruising, or 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 that are filled with pus.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require 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 you stop treatment with it, 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 not be around other persons living in your household who receive live virus vaccines because there is a chance that 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 amounts of cholesterol and fats in your blood. If this condition occurs, your doctor may give you some medicines that can lower the amounts. 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 you receive 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.

Side Effects of This Medicine:

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.