Brentuximab Vedotin

Brentuximab Vedotin is a prescription medicine used for the treatment of classical Hodgkin Lymphoma, Systemic Anaplastic Large Cell Lymphoma, Primary Cutaneous Anaplastic Large Cell Lymphoma, andCD30-expressing Peripheral T-cell Lymphomas.

• Brentuximab Vedotin is available under the following different brand names: Adcetris

Adult dosage

Injection, lyophilized powder for reconstitution

• 50mg/vial

Classical Hodgkin Lymphoma (cHL)

Adult dosage

• 1.2 mg/kg IV every 2 weeks  (in combination with AVD); not to exceed 120 mg/dose
• cHL consolidation
  • 1.8 mg/kg IV every 3 weeks; not to exceed 180 mg/dose
• Relapsed cHL
  • 1.8 mg/kg IV every 3 weeks; not to exceed 180 mg/dose

Systemic Anaplastic Large Cell Lymphoma

Adult dosage

• Previously-untreated systemic anaplastic large cell lymphoma (sALCL)
• 1.8 mg/kg IV every 3 weeks  for 6-8 doses; not to exceed 180 mg/dose

Relapsed sALCL

1. 1.8 mg/kg IV every 3 weeks; not to exceed 180 mg/dose

Primary Cutaneous Anaplastic Large Cell Lymphoma

Adult dosage

• 1.8 mg/kg IV every 3 weeks; not to exceed 180 mg/dose

CD30-expressing Peripheral T-cell Lymphomas

Adult dosage

• 1.8 mg/kg IV every 3 weeks for 6-8 doses; not to exceed 180 mg/dose

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of the Brentuximab Vedotin include:

• numbness,
• tingling,
• fever,
• low blood cells counts,
• nausea,
• vomiting,
• diarrhea,
• constipation, and
• tiredness.

Serious side effects of the Brentuximab Vedotin include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• fever,
• sore throat,
• burning in the eyes,
• skin pain,
• red or purple skin rash that spreads and causes blistering and peeling,
• dizziness,
• nausea,
• chills,
• itching,
• difficulty with speech, thought, vision, or muscle movement,
• numbness,
• weakness,
• burning pain,
• tingly feeling,
• loss of feeling in the arms or legs,
• sudden chest pain or pressure,
• wheezing,
• dry cough,
• shortness of breath,
• pain or burning while urinating,
• increased thirst,
• increased urination,
• dry mouth,
• fruity breath odor,
• vomiting,
• stomach pain,
• confusion,
• unusual drowsiness,
• fever,
• tiredness,
• mouth sores,
• skin sores,
• easy bruising,
• unusual bleeding,
• pale skin,
• cold hands and feet,
• lightheadedness,
• muscle cramps,
• fast or slow heart rate,
• decreased urination,
• tingling in the hands and feet or around the mouth,
• severe pain in the upper stomach spreading to the back,
• loss of appetite,
• stomach pain spreading to the upper right side,
• dark urine,
• yellowing of the skin or eyes (jaundice),
• severe constipation,
• new or worsening stomach pain,
• bloody or tarry stools,
• coughing up blood, and
• vomiting that looks like coffee grounds

Rare side effects of the Brentuximab Vedotin include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Brentuximab Vedotin has severe interactions with the following drug:
  • bleomycin
• Brentuximab Vedotin has serious interactions with the following drugs:
  • abametapir
  • apalutamide
  • erdafitinib
  • fexinidazole
  • idelalisib
  • ivosidenib
  • lasmiditan
  • lonafarnib
  • palifermin
  • selinexor
  • sotorasib
  • tepotinib
  • tucatinib
  • voxelotor
• Brentuximab Vedotin has moderate interactions with at least 58 other drugs.
• Brentuximab Vedotin has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Concomitant use of brentuximab with bleomycin because of pulmonary toxicity

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Brentuximab Vedotin?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Brentuximab Vedotin?”

Cautions

• Peripheral neuropathy (predominately sensory neuropathy) and motor neuropathy were reported; drug-induced peripheral neuropathy is cumulative; monitor for symptoms of neuropathy (eg, hypoesthesia, hyperesthesia, paresthesia, discomfort, a burning sensation, neuropathic pain, weakness)
• Fatal and serious cases of febrile neutropenia are reported; monitor complete blood counts (CBC) prior to each dose; start primary prophylaxis with G-CSF beginning with Cycle 1 for patients who receive drug with chemotherapy for previously untreated Stage III or IV cHL or previously untreated PTCL
• Grade 3 or 4 thrombocytopenia or anemia can occur
• The frequency of Grade 3 adverse reactions and deaths was reported to be greater in patients with severe renal or hepatic impairment compared to patients with normal renal/hepatic function
• Serious cases of hepatotoxicity, including fatal outcomes reported after the first dose or after rechallenge; serious cases of hepatotoxicity, including fatal outcomes; preexisting liver disease, elevated baseline liver enzymes, and concomitant medications may increase risk; monitor liver enzymes and bilirubin; patients experiencing new, worsening, or recurrent hepatotoxicity may require a delay, change in dose, or discontinuation of therapy
• JC virus infection resulting in progressive multifocal leukoencephalopathy (PML) and death reported (see Black Box Warnings)
• Closely monitor for the emergence of bacterial, fungal, or viral infections
• Events of noninfectious pulmonary toxicity (eg, pneumonitis, interstitial lung disease, acute respiratory distress syndrome [ARDS]), some with fatal outcomes, reported
• Fatal and serious cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are reported; if SJS or TEN occurs, discontinue treatment and administer appropriate medical therapy
• Acute pancreatitis, including fatal outcomes, reported
• Fatal and serious gastrointestinal (GI) complications (eg, perforation, hemorrhage, erosion, ulcer, intestinal obstruction, enterocolitis, neutropenic colitis, and ileus) are reported; lymphoma with preexisting GI involvement may increase the risk of perforation; promptly evaluate for any new or worsening GI symptoms, and treat appropriately
• Fetal harm can occur (see Pregnancy)
• Patients with rapidly proliferating tumors and high tumor burden are at risk of tumor lysis syndrome; closely monitor and treat appropriately
• Serious events of hyperglycemia (eg, new-onset hyperglycemia), exacerbation of preexisting diabetes mellitus, and ketoacidosis (including fatal outcomes) have been reported; occurred more frequently in patients with high body mass index or diabetes; monitor serum glucose and if hyperglycemia develops, administer antihyperglycemic medications as clinically indicated
• Infusion-related reactions
  • Infusion-related reactions (eg, anaphylaxis), may occur
  • If anaphylaxis occurs, immediately and permanently discontinue treatment
  • If an infusion-related reaction occurs, interrupt the infusion
  • After interrupting or discontinuing treatment, institute appropriate medical management
  • Premedicate patients who previously experienced infusion-related reactions for subsequent infusions
  • Premedication may include acetaminophen, an antihistamine, and a corticosteroid
• Drug interactions overview
  • Strong CYP3A4 Inhibitors
    • Coadministration with ketoconazole, a potent CYP3A4 inhibitor, increased exposure to MMAE which may increase the risk of adverse reaction
    • Closely monitor adverse reactions when concomitantly used with strong CYP3A4 inhibitors

Pregnancy and Lactation

• Based on the findings from animal studies and mechanism of action, brentuximab may cause fetal harm
• Available data from case reports in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes
• Contraception
  • Verify pregnancy status of females of reproductive potential prior to initiation
  • Advise females of reproductive potential to avoid pregnancy during treatment and for at least 6 months after the final dose; immediately report pregnancy
  • May damage spermatozoa and testicular tissue, resulting in possible genetic abnormalities
  • Use effective contraception in males with female sexual partners of reproductive potential during treatment and for at least 6 months after the final dose
• Fertility
  • Based on findings in rats, male fertility may be compromised by brentuximab
• Lactation
  • There is no information related to the presence of brentuximab Vedotin in human milk, the effects on the breastfed child, or the effects on milk production
  • Owing to the potential for serious adverse reactions in a breastfed child from brentuximab, including cytopenias and neurologic or gastrointestinal toxicities, breastfeeding is not recommended during treatment