Olanzapine, Olanzapine Pamoate and Ontak

• Generic Name: olanzapine
• Dosage Forms: n.a.
• Other Brand Names: Zyprexa, Zyprexa Zydis, Zyprexa Intramuscular, Zyprexa Relprevv

Orally (as olanzapine) and IM (as the long-acting olanzapine pamoate ester) for the acute and maintenance treatment of schizophrenia.

IM (as short-acting olanzapine) for management of acute agitation in patients with schizophrenia for whom treatment with olanzapine is appropriate and who require an IM antipsychotic agent for rapid control of behaviors that interfere with diagnosis and care.

American Psychiatric Association (APA) considers most atypical antipsychotic agents first-line drugs for management of the acute phase of schizophrenia (including first psychotic episodes).

Patients who do not respond to or tolerate one drug may be successfully treated with an agent from a different class or with a different adverse effect profile.

Orally for acute treatment of mixed or manic episodes associated with bipolar I disorder (as monotherapy and as adjunctive therapy with lithium or valproate).

Orally for maintenance treatment of bipolar I disorder (as monotherapy).

Orally for treatment (in combination with fluoxetine) of acute depressive episodes associated with bipolar I disorder. Olanzapine monotherapy is not indicated for treatment of depressive episodes associated with bipolar I disorder.

IM (as short-acting olanzapine) for management of acute agitation in patients with bipolar I disorder for whom treatment with olanzapine is appropriate and who require an IM antipsychotic agent for rapid control of behaviors that interfere with diagnosis and care.

Orally for acute and maintenance therapy (in combination with fluoxetine) of treatment-resistant depression (major depressive disorder in patients who do not respond to 2 separate trials of different antidepressants of adequate dosage and duration in the current episode).

Not indicated for treatment-resistant depression as monotherapy.

Has been used orally (in combination with other antiemetic agents) for prevention of acute and delayed nausea and vomiting associated with highly emetogenic cancer chemotherapy, including high-dose cisplatin therapy.

For prevention of nausea and vomiting associated with highly emetogenic chemotherapy regimens (including an anthracycline plus cyclophosphamide), ASCO recommends a 4-drug antiemetic regimen consisting of an NK1 receptor antagonist (e.g., aprepitant, fosaprepitant, netupitant [in fixed combination with palonosetron], rolapitant), a 5-HT3 receptor antagonist (e.g., dolasetron, granisetron, ondansetron, palonosetron, ramosetron [not commercially available in the US], tropisetron [not commercially available in the US]), dexamethasone, and olanzapine. If the fixed combination of netupitant and palonosetron is used as an NK1 receptor antagonist, use of an additional 5-HT3 receptor antagonist is not necessary.

Clinical experience with oral olanzapine in adults receiving moderately emetogenic chemotherapy is limited; ASCO does not recommend olanzapine in such patients. For adults receiving carboplatin with a target AUC of ≥4 mg/mL per minute, ASCO recommends a 3-drug antiemetic regimen consisting of an NK1 receptor antagonist, a 5-HT3 receptor antagonist, and dexamethasone. For adults receiving other chemotherapy of moderate emetic risk, excluding carboplatin with a target AUC of ≥4 mg/mL per minute, ASCO recommends a 2-drug antiemetic regimen consisting of a 5-HT3 receptor antagonist and dexamethasone.

For chemotherapy regimens with low emetic risk, ASCO recommends a single dose of either a 5-HT3 receptor antagonist or dexamethasone alone on the first day of chemotherapy.

For chemotherapy regimens with minimal emetic risk, ASCO states that routine antiemetic prophylaxis is not necessary.

Olanzapine also has been shown to be an effective rescue antiemetic in patients who develop breakthrough chemotherapy-induced nausea and vomiting despite optimal antiemetic prophylaxis.

For patients with breakthrough chemotherapy-induced nausea or vomiting, ASCO recommends clinicians reevaluate emetic risk, disease status, and concomitant medical conditions and medications and determine whether the best antiemetic regimen is being provided for the emetic risk. In adults who experience nausea and vomiting despite optimal antiemetic prophylaxis and who have not received olanzapine prophylactically, ASCO states that olanzapine may be added to the standard antiemetic regimen. In adults who experience nausea or vomiting despite optimal antiemetic prophylaxis and who have already received olanzapine, may add an antiemetic drug from a different class (i.e., an NK1 receptor antagonist, lorazepam or alprazolam, a dopamine receptor antagonist [e.g., metoclopramide], dronabinol or nabilone) to the standard antiemetic regimen.

• Generic Name: denileukin diftitox
• Dosage Forms: injection, solution
• Other Brand Names: Ontak

Treatment of persistent or recurrent cutaneous T-cell lymphoma (CTCL) in patients whose malignant cells express the CD25 component of the IL-2 receptor (designated an orphan drug by FDA for this use).

Safety and efficacy in patients with CTCL whose malignant cells do not express the CD25 component of the IL-2 receptor not established but currently being studied.