Brentuximab Intravenous

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 brentuximab, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to brentuximab 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.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of brentuximab injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies have not been performed on the relationship of age to the effects of brentuximab injection in the geriatric population.

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.

Interactions with 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 brentuximab, 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 brentuximab with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Bleomycin

Using brentuximab 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.

• Atazanavir
• Boceprevir
• Ceritinib
• Delavirdine
• Idelalisib
• Indinavir
• Nefazodone
• Nelfinavir
• Posaconazole
• Saquinavir
• Telithromycin
• Tipranavir
• Voriconazole

Interactions with Food/Tobacco/Alcohol

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using brentuximab with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use brentuximab, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of brentuximab. Make sure you tell your doctor if you have any other medical problems, especially:

• Infection—May decrease your body's ability to fight an infection.

• Kidney disease or
• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Lung problems (eg, cough, shortness of breath) or
• Neutropenia (low white blood cells) or
• Peripheral neuropathy (nerve problem) or
• Pneumonitis (inflammation of the lung) or
• Stomach or intestinal bleeding or
• Stomach ulcer or
• Thrombocytopenia (low platelets in the blood)—Use with caution. May make these conditions worse.

Before receiving brentuximab, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

You will receive brentuximab in a hospital or cancer treatment center. A nurse or other trained health professional will give you brentuximab. brentuximab is given through a needle placed in one of your veins.

You may also receive medicines (eg, acetaminophen, antihistamines, steroids) to help prevent possible allergic reactions to the injection.

More frequently reported side effects include: peripheral motor neuropathy. See below for a comprehensive list of adverse effects.

Applies to brentuximab: intravenous powder for injection

Dermatologic

Very common (10% or more): Rash (up to 31%), pruritus (up to 19%), alopecia (up to 14), night sweats (up to 12%), dry skin (up to 10%)
Rare (less than 0.1%): : Stevens-Johnson syndrome (SJS) (including fatal outcomes), toxic epidermal necrolysis (including fatal outcomes)[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 42%), diarrhea (up to 36%), abdominal pain (up to 25%), vomiting (up to 22%), constipation (up to 19%)
Postmarketing reports: Pancreatitis (including fatal outcomes)[Ref]

Hematologic

Very common (10% or more): Neutropenia (any grade) (up to 78%), anemia (up to 52%), thrombocytopenia (up to 41%), lymphadenopathy (up to 11%)
Postmarketing reports: Febrile neutropenia[Ref]

Hypersensitivity

Frequency not reported: Anaphylactic reaction[Ref]

Metabolic

Very common (10% or more): Weight decreased (up to 19%), decreased appetite (up to 11%)
Common (1% to 10%): Hyperglycemia[Ref]

Musculoskeletal

Very common (10% or more): Arthralgia (up to 19%), myalgia (up to 17%), back pain (up to 14%), pain in extremity (up to 10%)
Common (1% to 10%): Muscle spasms[Ref]

Nervous system

Very common (10% or more): Peripheral sensory neuropathy (up to 56%), peripheral motor neuropathy (up to 23%), headache (up to 19%), dizziness (up to 16%)
Common (1% to 10%): Demyelinating polyneuropathy
Frequency not reported: Progressive multifocal leukoencephalopathy[Ref]

Other

Other side effects have included infusion related reactions (12%) including chills, nausea, dyspnea, pruritus, pyrexia and cough.[Ref]

Psychiatric

Very common (10% or more): Insomnia (up to 16%), anxiety (up to 11%)[Ref]

Respiratory

Very common (10% or more): Upper respiratory infection (up to 47%), cough (up to 25%), dyspnea (up to 17%), oropharyngeal pain (up to 11%)
Postmarketing reports: Noninfectious pulmonary toxicity (including fatal outcomes)[Ref]

Hepatic

Common (1% to 10%): Alanine aminotransferase/aspartate aminotransferase (ALT/AST) increased
Postmarketing reports: Hepatotoxicity[Ref]

Immunologic

Very common (10% or more): Infection
Common (1% to 10%): Sepsis/septic shock, pneumonia, herpes zoster
Uncommon (0.1% to 1%): Oral candidiasis, pneumocystis jiroveci pneumonia, staphylococcal bacteremia
Postmarketing reports: Serious opportunistic infections[Ref]

Oncologic

Uncommon (0.1% to 1%): Tumor lysis syndrome[Ref]

Some side effects of brentuximab may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Initial dose: 1.8 mg/kg IV over 30 minutes every 3 weeks
Maximum dose: 180 mg

Comments:
-Administer as an IV infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity.
-For classical HL post-auto-HSCT consolidation treatment, treatment should be initiated within 4 to 6 weeks post-auto-HSCT or upon recovery from auto-HSCT. These patients should continue treatment until a maximum of 16 cycles, disease progression, or unacceptable toxicity.

Uses:
-Classical HL after failure of autologous hematopoietic stem cell transplantation (auto-HSCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates
-For the treatment of patients with classical HL at high risk of relapse or progression as post-auto-HSCT consolidation
-For treatment of patients with systemic anaplastic large cell lymphoma sALCL after failure of at least one prior multi-agent chemotherapy regimen

Data not available