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Akynzeo

Last reviewed on RxList: 5/7/2018
Akynzeo Side Effects Center

Last reviewed on RxList 5/7/2018

Akynzeo (netupitant and palonosetron) is a combination of anti-nausea and anti-emetic drugs used for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. Common side effects of Akynzeo include:

The recommended dosage in adults is one capsule of Akynzeo administered approximately 1 hour prior to the start of chemotherapy with dexamethasone 12 mg administered orally 30 minutes prior to chemotherapy on day 1, and 8 mg orally once daily on days 2 to 4. Akynzeo may interact with midazolam, chemotherapy drugs, palonosetron, rifampin, ketoconazole, serotonin reuptake inhibitors (SSRIs), and serotonin and noradrenaline reuptake inhibitors (SNRIs). Tell your doctor all medications and supplements you use. During pregnancy, should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Akynzeo (netupitant and palonosetron) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Akynzeo Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; chest pain, difficult breathing; swelling of your face, lips, tongue, or throat.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Common side effects may include:

  • headache;
  • feeling weak or tired;
  • skin redness; or
  • upset stomach, constipation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Akynzeo (Netupitant and Palonosetron Capsules)

Akynzeo Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are found elsewhere in the labeling:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

AKYNZEO Capsules

The overall safety of AKYNZEO capsules was evaluated in 1538 cancer patients and healthy subjects in clinical trials. The data described below reflect exposure to AKYNZEO in 1169 cancer patients, receiving at least one cycle of cancer chemotherapy in 3 active-controlled trials [see Clinical Studies], including 782 exposed to AKYNZEO for at least 4 cycles and 321 exposed for at least 6 cycles, up to a maximum of 12 cycles of chemotherapy. The median age was 55, 79% were female, 83% were White, 13% were Asian, and 4% were Hispanic. All patients received a single oral dose of AKYNZEO 1 hour prior to the start of each chemotherapy cycle. In all studies, dexamethasone was co-administered with AKYNZEO [see Clinical Studies, Table 14 and Table 16].

Cisplatin Based Highly Emetogenic Chemotherapy

In a single-cycle study of patients receiving cisplatin based highly emetogenic chemotherapy, 136 patients were treated with AKYNZEO. Table 3 shows adverse reactions reported at an incidence of at least 3% and for which the AKYNZEO rate exceeded palonosetron alone.

Table 3: Adverse Reactions Occurring in ≥3% of Cancer Patients Receiving AKYNZEO Capsules and Cisplatin Based Highly Emetogenic Chemotherapy (Cycle 1)

Adverse Reactions AKYNZEO Capsules netupitant 300 mg/ palonosetron 0.5 mg
(N=136)
Palonosetron 0.5 mg
(N=136)
Dyspepsia 4% 2%
Fatigue 4% 2%
Constipation 3% 1%
Erythema 3% 2%

Anthracyclines And Cyclophosphamide Based Chemotherapy

In a study of patients receiving anthracycline and cyclophosphamide based chemotherapy, 725 patients were treated with AKYNZEO capsules during Cycle 1, and 635 of these patients continued for up to 8 cycles in a multiple-cycle extension. Table 4 shows adverse reactions reported at an incidence of at least 3% and for which the AKYNZEO capsules rate exceeded palonosetron alone during Cycle 1. The adverse reaction profile in subsequent cycles was similar to that observed in Cycle 1.

Table 4: Adverse Reactions Occurring in ≥3% of Cancer Patients Receiving AKYNZEO Capsules and Anthracyclines and Cyclophosphamide Based Chemotherapy (Cycle 1)

Adverse Reactions AKYNZEO Capsules netupitant 300 mg/palonosetron 0.5 mg
(N=725)
Palonosetron 0.5 mg
(N=725)
Headache 9% 7%
Asthenia 8% 7%
Fatigue 7% 5%

In addition to the adverse reactions shown above, there were reports of concomitant elevations of transaminases greater than 3 times the upper limit of normal and total bilirubin in both arms of the two trials that compared AKYNZEO capsules to oral palonosetron, and the frequency of these elevations was comparable between treatment groups. See Table 5.

Table 5: Liver Function Laboratory Abnormalities

Laboratory Changes AKYNZEO Capsules netupitant 300 mg/palonosetron 0.5 mg
(N=861)
Palonosetron 0.5 mg
(N=861)
AST > 3 x ULN and/or ALT > 3 x ULN with Total Bilirubin > ULN 3 (0.3%) 5 (0.6%)
AST > 10 x ULN and/or ALT > 10 x ULN with Total Bilirubin > ULN - 2 (0.2%)
AST > 3 x ULN and/or ALT > 3 x ULN with Total Bilirubin ≥ 2 x ULN 1 (0.1%) 1 (0.1%)
ULN = upper limit of normal

In a multi-cycle safety study of 412 patients, the safety profile of AKYNZEO capsules (n = 308) was comparable to aprepitant and palonosetron (n = 104) in patients undergoing initial and repeat cycles (median 5 cycles, range of 1-14 cycles) of chemotherapy, including carboplatin, cisplatin, oxaliplatin, and doxorubicin regimens. There were no reports of concomitant elevations of transaminases greater than 3 times the upper limit of normal and total bilirubin in this study in either arm.

In a randomized, clinical non-inferiority study, that compared oral palonosetron 0.5 mg to intravenous palonosetron 0.25 mg in cancer patients scheduled to receive highly emetogenic cisplatin (greater than or equal to 70 mg/m²) based chemotherapy, there were two patients (0.5%; 2/369) in the intravenous palonosetron arm who had concomitant elevations of transaminases and total bilirubin. Neither experienced transaminase elevations greater than 10 times the upper limit of normal.

AKYNZEO For Injection

The safety of AKYNZEO for injection was evaluated in 203 patients in an active-controlled multi-cycle (median 4 cycles, range of 1-4 cycles) safety clinical study in patients receiving HEC regimens, not including anthracycline plus cyclophosphamide, (e.g., cisplatin, cyclophosphamide, carmustine, dacarbazine and mechloretamine) compared to 201 patients receiving AKYNZEO capsules (NCT02517021). The median age was 60 years, 46% were female, 99.5 % were White, 0.3% were Asian, and 0.3% were Hispanic. All patients received a single dose of AKYNZEO for injection 30 minutes prior to the start of each chemotherapy cycle; dexamethasone was co-administered with AKYNZEO. The safety profile of AKYNZEO for injection was generally similar to that seen with AKYNZEO capsules.

Read the entire FDA prescribing information for Akynzeo (Netupitant and Palonosetron Capsules)

Related Resources for Akynzeo

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© Akynzeo Patient Information is supplied by Cerner Multum, Inc. and Akynzeo Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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