Usual Adult Dose for Colorectal Cancer

In combination with bolus-IFL: 5 mg/kg IV every 2 weeks
In combination with FOLFOX4: 10 mg/kg IV every 2 weeks
In combination with a fluoropyrimidine-irinotecan or fluoropyrimidine-oxaliplatin based chemotherapy regimen in patients who have progressed on a first-line bevacizumab-containing regimen: 5 mg/kg IV every 2 weeks or 7.5 mg/kg IV every 3 weeks

Duration of therapy: Until disease progression or unacceptable toxicity

Comments:

• Administer the first infusion over 90 minutes, the second over 60 minutes if first infusion is tolerated, and all subsequent infusions over 30 minutes if infusion over 60 minutes is tolerated.

Use:

• For first or second line therapy of patients with metastatic carcinoma of the colon or rectum in combination with IV 5-fluorouracil-based chemotherapy
• For second line therapy of patients with metastatic colorectal cancer who have progressed on a first-line bevacizumab-containing regimen, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy

Usual Adult Dose for Non-Small Cell Lung Cancer

In combination with carboplatin and paclitaxel: 15 mg/kg IV every 3 weeks

Duration of therapy: Until disease progression or unacceptable toxicity

Comments:

• Administer the first infusion over 90 minutes, the second over 60 minutes if first infusion is tolerated, and all subsequent infusions over 30 minutes if infusion over 60 minutes is tolerated.

Use: For first-line therapy of unresectable, locally advanced, recurrent, or metastatic non-squamous non-small cell lung cancer in combination with carboplatin and paclitaxel

Usual Adult Dose for Glioblastoma Multiforme

10 mg/kg IV every 2 weeks

Duration of therapy: Until disease progression or unacceptable toxicity

Comments:

• Administer the first infusion over 90 minutes, the second over 60 minutes if first infusion is tolerated, and all subsequent infusions over 30 minutes if infusion over 60 minutes is tolerated.

Use: For the treatment of recurrent glioblastoma in adults

Usual Adult Dose for Renal Cell Carcinoma

In combination with interferon alfa: 10 mg/kg IV every 2 weeks

Duration of therapy: Until disease progression or unacceptable toxicity

Comments:

• Administer the first infusion over 90 minutes, the second over 60 minutes if first infusion is tolerated, and all subsequent infusions over 30 minutes if infusion over 60 minutes is tolerated.

Use: For metastatic renal cell carcinoma in combination with interferon alfa

Usual Adult Dose for Cervical Cancer

In combination with paclitaxel and cisplatin OR paclitaxel and topotecan: 15 mg/kg IV every 3 weeks

Comments:

• Administer the first infusion over 90 minutes, the second over 60 minutes if first infusion is tolerated, and all subsequent infusions over 30 minutes if infusion over 60 minutes is tolerated.

Use: For persistent, recurrent, or metastatic carcinoma of the cervix in combination with paclitaxel and cisplatin or paclitaxel and topotecan

Usual Adult Dose for Ovarian Cancer

TREATMENT OF STAGE III OR IV DISEASE FOLLOWING INITIAL SURGICAL RESECTION:
15 mg/kg IV every 3 weeks in combination with carboplatin and paclitaxel for up to 6 cycles, followed by bevacizumab 15 mg/kg IV every 3 weeks as a single agent, for a total of up to 22 cycles or until disease progression, whichever occurs earlier

TREATMENT OF RECURRENT DISEASE:
PLATINUM RESISTANT:
10 mg/kg IV every 2 weeks in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan (every week)

• Give 15 mg/kg IV every 3 weeks in combination with topotecan (every 3 weeks)

PLATINUM SENSITIVE:

• Give 15 mg/kg IV every 3 weeks, in combination with carboplatin and paclitaxel for 6 to 8 cycles, followed by bevacizumab 15 mg/kg IV every 3 weeks as a single agent until disease progression
• Give 15 mg/kg IV every 3 weeks, in combination with carboplatin and gemcitabine for 6 to 10 cycles, followed by bevacizumab 15 mg/kg every 3 weeks as a single agent until disease progression

Comments:

• Administer the first infusion over 90 minutes, the second over 60 minutes if first infusion is tolerated, and all subsequent infusions over 30 minutes if infusion over 60 minutes is tolerated.

Uses:

• In combination with carboplatin and paclitaxel, followed by bevacizumab as a single agent, for the treatment of patients with stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection
• In combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan, for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens
• In combination with carboplatin and paclitaxel, or with carboplatin and gemcitabine, followed by bevacizumab as a single agent, for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer

Usual Adult Dose for Fallopian Tube Cancer

TREATMENT OF STAGE III OR IV DISEASE FOLLOWING INITIAL SURGICAL RESECTION:
15 mg/kg IV every 3 weeks in combination with carboplatin and paclitaxel for up to 6 cycles, followed by bevacizumab 15 mg/kg IV every 3 weeks as a single agent, for a total of up to 22 cycles or until disease progression, whichever occurs earlier

TREATMENT OF RECURRENT DISEASE:
PLATINUM RESISTANT:
10 mg/kg IV every 2 weeks in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan (every week)

• Give 15 mg/kg IV every 3 weeks in combination with topotecan (every 3 weeks)

PLATINUM SENSITIVE:

• Give 15 mg/kg IV every 3 weeks, in combination with carboplatin and paclitaxel for 6 to 8 cycles, followed by bevacizumab 15 mg/kg IV every 3 weeks as a single agent until disease progression
• Give 15 mg/kg IV every 3 weeks, in combination with carboplatin and gemcitabine for 6 to 10 cycles, followed by bevacizumab 15 mg/kg every 3 weeks as a single agent until disease progression

Comments:

• Administer the first infusion over 90 minutes, the second over 60 minutes if first infusion is tolerated, and all subsequent infusions over 30 minutes if infusion over 60 minutes is tolerated.

Uses:

• In combination with carboplatin and paclitaxel, followed by bevacizumab as a single agent, for the treatment of patients with stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection
• In combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan, for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens
• In combination with carboplatin and paclitaxel, or with carboplatin and gemcitabine, followed by bevacizumab as a single agent, for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer

Usual Adult Dose for Peritoneal Cancer

TREATMENT OF STAGE III OR IV DISEASE FOLLOWING INITIAL SURGICAL RESECTION:
15 mg/kg IV every 3 weeks in combination with carboplatin and paclitaxel for up to 6 cycles, followed by bevacizumab 15 mg/kg IV every 3 weeks as a single agent, for a total of up to 22 cycles or until disease progression, whichever occurs earlier

TREATMENT OF RECURRENT DISEASE:
PLATINUM RESISTANT:
10 mg/kg IV every 2 weeks in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan (every week)

• Give 15 mg/kg IV every 3 weeks in combination with topotecan (every 3 weeks)

PLATINUM SENSITIVE:

• Give 15 mg/kg IV every 3 weeks, in combination with carboplatin and paclitaxel for 6 to 8 cycles, followed by bevacizumab 15 mg/kg IV every 3 weeks as a single agent until disease progression
• Give 15 mg/kg IV every 3 weeks, in combination with carboplatin and gemcitabine for 6 to 10 cycles, followed by bevacizumab 15 mg/kg every 3 weeks as a single agent until disease progression

Comments:

• Administer the first infusion over 90 minutes, the second over 60 minutes if first infusion is tolerated, and all subsequent infusions over 30 minutes if infusion over 60 minutes is tolerated.

Uses:

• In combination with carboplatin and paclitaxel, followed by bevacizumab as a single agent, for the treatment of patients with stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection
• In combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan, for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens
• In combination with carboplatin and paclitaxel, or with carboplatin and gemcitabine, followed by bevacizumab as a single agent, for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer

Usual Adult Dose for Hepatocellular Carcinoma

15 mg/kg IV (after administration of atezolizumab 1200 mg IV on the same day) every 3 weeks until disease progression or unacceptable toxicity

Comments:

• Administer the first infusion over 90 minutes, the second over 60 minutes if first infusion is tolerated, and all subsequent infusions over 30 minutes if infusion over 60 minutes is tolerated.
• Refer to the Prescribing Information for atezolizumab prior to initiation for recommended dosage information

Use: In combination with atezolizumab for patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

No dose reductions are recommended for this drug.

If proteinuria develops and is greater than or equal to 2 grams per 24 hours in absence of nephrotic syndrome: Withhold this drug until proteinuria is less than 2 grams per 24 hours.

If wound healing complications of any grade develop: Withhold this drug until adequate wound healing; the safety of resumption after resolution of wound healing complications has not been established.

If a clinically significant infusion reaction occurs that is not severe: Interrupt the infusion and resume at a decreased rate after symptoms resolve.

Discontinue this drug for any of the following:

• Any Grade GI perforation
• Any Grade tracheoesophageal fistula
• Grade 4 fistula
• Fistula formation involving any internal organ
• Necrotizing fasciitis
• Grade 3 or 4 hemorrhage
• Recent history of hemoptysis of 2.5 mL or more
• Severe arterial thromboembolism
• Grade 4 venous thromboembolism
• Hypertensive crisis
• Hypertensive encephalopathy
• Severe hypertension
• Any severity of renal toxicity and proteinuria
• Severe infusion reaction
• Any congestive heart failure

Precautions

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• The first dose should be infused over 90 minutes following chemotherapy. If it is well tolerated, the second dose may be infused over 60 minutes. If the 60 minute infusion is well tolerated, all subsequent doses may be infused over 30 minutes.
• Do not administer as an IV push or bolus.
• Do not administer this drug to patients with recent history of hemoptysis of 1/2 teaspoon or more of red blood.
• Discontinue in patients who develop a Grade 3 or 4 hemorrhage.
• Do not administer as an IV push or bolus.
• Do not administer this drug until at least 28 days following surgery and the wound is fully healed.

General:

• Do not initiate therapy for at least 28 days following major surgery and the surgical incision is fully healed.
• Prepare, administer, and dispose of this drug according to standard protocols for antineoplastic drugs.
• This drug is not formulated for intravitreal use.

Monitoring:

• Hypersensitivity: Infusion-related reactions
• Cardiovascular: Blood pressure monitoring for hypertension
• Renal: Proteinuria
• Common adverse events: Arterial or venous thromboembolic events, GI perforation, fistulae, delayed wound healing, hemorrhage (including tumor-associated hemorrhage), congestive heart failure, neutropenia, osteonecrosis of the jaw, and reversible posterior leukoencephalopathy syndrome.

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