|
ADCETRIS® (brentuximab vedotin) for injection is now approved for use in pediatric patients
2 years and
older with previously untreated high risk classical Hodgkin lymphoma (cHL), in combination with
doxorubicin, vincristine, etoposide, prednisone and cyclophosphamide.1
|
|
Indication and Recommended Dosage
|
|
|
ADCETRIS is a CD30-directed antibody-drug conjugate indicated for treatment of pediatric patients 2
years and older with previously untreated high risk classical Hodgkin lymphoma (cHL), in combination
with doxorubicin, vincristine, etoposide, prednisone and, cyclophosphamide.1
|
|
The recommended dosage in combination with chemotherapy for pediatric patients 2 years and older
with previously untreated
high risk cHL is 1.8 mg/kg up to a maximum of 180 mg every 3 weeks for a maximum of 5
doses.1 Please refer to Prescribing Information for full dosage and administration
information.
|
|
Please see the Important Safety Information below and click here for Prescribing Information,
including BOXED WARNING
|
|
HCPCS Code2 |
Description |
Billing Unit |
|
J9042 |
Injection, brentuximab vedotin, 1mg |
1mg=1 billing unit |
|
|
NDC Code1 |
Description |
Note |
|
51144-050-01 |
50 mg brentuximab vedotin |
Payer requirements regarding use of a 10-digit or 11-digit NDC may vary. |
|
|
|
IMPORTANT SAFETY INFORMATION
|
|
|
|
BOXED WARNING
|
|
|
PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML): JC virus infection resulting in PML and death can
occur in ADCETRIS-treated patients.
|
|
|
|
|
CONTRAINDICATION
|
|
Contraindicated with concomitant bleomycin due to pulmonary toxicity (e.g., interstitial
infiltration and/or inflammation).
|
|
WARNINGS AND PRECAUTIONS
|
|
Peripheral
neuropathy (PN): ADCETRIS causes PN that is predominantly sensory. Cases of motor PN have
also been reported. ADCETRIS-induced PN is cumulative. Monitor for symptoms such as hypoesthesia,
hyperesthesia, paresthesia, discomfort, a burning sensation, neuropathic pain, or weakness. Patients
experiencing
|
|
Anaphylaxis and
infusion reactions: Infusion-related reactions (IRR), including anaphylaxis, have occurred
with ADCETRIS. Monitor patients during infusion. If an IRR occurs, interrupt the infusion and
institute appropriate medical management. If anaphylaxis occurs, immediately and permanently
discontinue the infusion and administer appropriate medical therapy. Premedicate patients with a
prior IRR before subsequent infusions. Premedication may include acetaminophen, an antihistamine,
and a corticosteroid.
|
|
Hematologic
toxicities: Fatal and serious cases of febrile neutropenia have been reported with
ADCETRIS. Prolonged (≥1 week) severe neutropenia and Grade 3 or 4 thrombocytopenia or anemia can
occur with ADCETRIS.
|
|
Administer G-CSF primary prophylaxis beginning with Cycle 1 for adult patients who receive ADCETRIS
in combination with chemotherapy for previously untreated Stage III/IV cHL or previously untreated
PTCL, and pediatric patients who receive ADCETRIS in combination with chemotherapy for previously
untreated high risk cHL.
|
|
Monitor complete blood counts prior to each ADCETRIS dose. Monitor more frequently for patients with
Grade 3 or 4 neutropenia. Monitor patients for fever. If Grade 3 or 4 neutropenia develops, consider
dose delays, reductions, discontinuation, or G-CSF prophylaxis with subsequent doses.
|
|
Serious infections
and opportunistic infections: Infections such as pneumonia, bacteremia, and sepsis or
septic shock (including fatal outcomes) have been reported in ADCETRIS-treated patients. Closely
monitor patients during treatment for infections.
|
|
Tumor lysis
syndrome: Patients with rapidly proliferating tumor and high tumor burden may be at
increased risk. Monitor closely and take appropriate measures.
|
|
Increased toxicity
in the presence of severe renal impairment: The frequency of ≥Grade 3 adverse reactions and
deaths was greater in patients with severe renal impairment. Avoid use in patients with severe renal
impairment.
|
|
Increased toxicity
in the presence of moderate or severe hepatic impairment: The frequency of ≥Grade 3 adverse
reactions and deaths was greater in patients with moderate or severe hepatic impairment. Avoid use
in patients with moderate or severe hepatic impairment.
|
|
Hepatotoxicity:
Fatal and serious cases have occurred in ADCETRIS-treated patients. Cases were consistent with
hepatocellular injury, including elevations of transaminases and/or bilirubin, and occurred after
the first ADCETRIS dose or rechallenge. Preexisting liver disease, elevated baseline liver enzymes,
and concomitant medications may increase the risk. Monitor liver enzymes and bilirubin. Patients
with new, worsening, or recurrent hepatotoxicity may require a delay, change in dose, or
discontinuation of ADCETRIS.
|
|
PML:
Fatal cases of JC virus infection resulting in PML have been
reported in ADCETRIS-treated patients. First onset of symptoms occurred at various times from
initiation of ADCETRIS, with some cases occurring within 3 months of initial exposure. In addition
to ADCETRIS therapy, other possible contributory factors include prior therapies and underlying
disease that may cause immunosuppression. Consider PML diagnosis in patients with new-onset signs
and symptoms of central nervous system abnormalities. Hold ADCETRIS if PML is suspected and
discontinue ADCETRIS if PML is confirmed.
|
|
Pulmonary
toxicity: Fatal and serious events of
noninfectious pulmonary toxicity, including pneumonitis, interstitial lung disease, and acute
respiratory distress syndrome, have been reported. Monitor patients for signs and symptoms,
including cough and dyspnea. In the event of new or worsening pulmonary symptoms, hold ADCETRIS
dosing during evaluation and until symptomatic improvement.
|
|
Serious
dermatologic reactions: Fatal and serious cases of Stevens-Johnson syndrome (SJS) and toxic
epidermal necrolysis (TEN) have been reported with ADCETRIS. If SJS or TEN occurs, discontinue
ADCETRIS and administer appropriate medical therapy.
|
|
Gastrointestinal
(GI) complications: Fatal and
serious cases of acute pancreatitis have been reported. Other fatal and serious GI complications
include perforation, hemorrhage, erosion, ulcer, intestinal obstruction, enterocolitis, neutropenic
colitis, and ileus. Lymphoma with preexisting GI involvement may increase the risk of perforation.
In the event of new or worsening GI symptoms, including severe abdominal pain, perform a prompt
diagnostic evaluation and treat appropriately.
|
|
Hyperglycemia: Serious cases, such as new-onset
hyperglycemia, exacerbation of preexisting diabetes mellitus, and ketoacidosis (including fatal
outcomes) have been reported with ADCETRIS. Hyperglycemia occurred more frequently in patients with
high body mass index or diabetes. Monitor serum glucose and if hyperglycemia develops, administer
anti-hyperglycemic medications as clinically indicated.
|
|
Based on the mechanism
of action and animal studies, ADCETRIS can cause fetal harm. Advise females of reproductive
potential of this potential risk, and to avoid pregnancy during ADCETRIS treatment and for 6
months
after the last dose of ADCETRIS.
|
|
ADVERSE REACTIONS
|
|
The most common adverse reactions (≥20% in any study) are peripheral neuropathy, fatigue,
nausea, diarrhea, neutropenia, upper respiratory tract infection, pyrexia, constipation, vomiting,
alopecia, decreased weight, abdominal pain, anemia, stomatitis, lymphopenia, mucositis,
thrombocytopenia, and febrile neutropenia.
|
|
DRUG INTERACTIONS
|
|
Concomitant use of strong CYP3A4 inhibitors has the potential to affect the exposure to
monomethyl auristatin E (MMAE). Closely monitor adverse reactions.
|
|
USE IN SPECIAL POPULATIONS
|
|
Lactation:
Breastfeeding is not recommended during ADCETRIS treatment.
|
|
Females and Males
of Reproductive Potential: Advise females to report pregnancy immediately and advise males
with female sexual partners of reproductive potential to use effective contraception during ADCETRIS
treatment and for 6 months after the last dose of ADCETRIS.
|
|
Reference
- ADCETRIS (brentuximab vedotin) [Prescribing
Information]. Bothell, WA: Seagen Inc November 2022.
-
Centers for Medicare & Medicaid Services. 2020 alpha-numeric HCPCS file.
https://www.cms.gov/Medicare/Coding/HCPCSReleaseCodeSets/Alpha-Numeric-HCPCS-Items/2020-Alpha-Numeric-HCPCS-File.
File Name: HCPC2020_ANWEB_w_disclaimer.xls. Accessed November 21, 2022.
|
|
