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What is Akynzeo, and how does it work?
Akynzeo is a prescription medicine called an “antiemetic.” Akynzeo is used in combination with the medicine dexamethasone in people to help prevent the nausea and vomiting that happens right away or later with certain anticancer medicines (chemotherapy). It is not known if Akynzeo is safe and effective in children under 18 years of age.
What are the side effects of Akynzeo?
Akynzeo may cause serious side effects, including:
- allergic reactions, such as anaphylaxis. Get emergency medical help right away if you get any of the following symptoms of a serious allergic reaction with Akynzeo: hives, swollen face, trouble breathing, or chest pain.
- serotonin syndrome which can happen with Akynzeo particularly with certain other medicines such as antidepressants and anti-migraine medicines and can lead to death.
Stop taking Akynzeo capsules and go to the nearest hospital emergency room right away if you get any of the following symptoms of serotonin syndrome:
- agitation,
- hallucinations or other changes in mental status,
- dizziness,
- fast heartbeat,
- sweating,
- low body temperature,
- shaking (tremors),
- unsteady movements,
- muscle twitching (overactive reflexes), or
- seizures with or without nausea,
- vomiting, and
- diarrhea.
The most common side effects of Akynzeo capsules and injection include:
- headache,
- weakness,
- fatigue,
- upset stomach,
- constipation, and
- skin redness.
These are not all the possible side effects of Akynzeo. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is the dosage for Akynzeo?
The recommended dosages of Akynzeo and dexamethasone in
adults for the prevention of nausea and vomiting associated with administration
of emetogenic chemotherapy are shown in Table 1.
Akynzeo capsules can be taken with or without food.
Table 1: Antiemetic Treatment Regimen
Treatment Regimen
Day 1
Days 2 to 4
Highly Emetogenic Chemotherapy, including Cisplatin-Based Chemotherapy
Akynzeo capsules
1 capsule of Akynzeo
1 hour before chemotherapy
Dexamethasone 8 mg once a day
Dexamethasone 12 mg
30 minutes before chemotherapy
Akynzeo for injection
1 vial of Akynzeo
Infuse over 30 minutes starting 30 minutes before chemotherapy [see Preparation and Administration of
Akynzeo for injection]
Dexamethasone 8 mg once a day
Dexamethasone 12 mg
30 minutes before chemotherapy
Anthracyclines and Cyclophosphamide-Based Chemotherapy and Chemotherapy Not Considered Highly Emetogenic
Akynzeo capsules
1 capsule of Akynzeo
1 hour before chemotherapy
None
Dexamethasone 12 mg
30 minutes before chemotherapy
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What drugs interact with Akynzeo?
Effects Of Akynzeo On Other Drugs
Interaction With CYP3A4 Substrates
- Netupitant is a moderate inhibitor of CYP3A4.
- Akynzeo should be used with caution in patients receiving
concomitant medications that are primarily metabolized through CYP3A4. - A single
oral dose of netupitant 300 mg significantly inhibits CYP3A4 for 6 days. - Avoid
concomitant use of drugs that are CYP3A4 substrates for one week, if feasible.
If not avoidable, consider dose reduction of CYP3A4 substrates.
Dexamethasone
- A single oral dose of netupitant 300 mg or a single fosnetupitant
infusion of 235 mg increased the systemic exposure of concomitant
dexamethasone more than 2-fold on Days 2 and 4. Administer a reduced dose of
dexamethasone with Akynzeo.
Midazolam
- When administered with netupitant, the systemic exposure to midazolam
was significantly increased. Consider the potential effects of increased
plasma concentrations of midazolam or other benzodiazepines metabolized via
CYP3A4 (alprazolam, triazolam) when administering these drugs with Akynzeo.
Chemotherapeutic Agents
- The systemic exposure of chemotherapy agents metabolized by CYP3A4 can
increase when administered with Akynzeo. - Chemotherapy agents that are known to be metabolized by CYP3A4 include
docetaxel, paclitaxel, etoposide, irinotecan, cyclophosphamide, ifosfamide,
imatinib, vinorelbine, vinblastine, and vincristine. - Caution and monitoring for
chemotherapeutic related adverse reactions are advised in patients receiving
chemotherapy agents metabolized primarily by CYP3A4.
Oral Contraceptives
- There is no clinically significant effect of Akynzeo on the efficacy of
oral contraceptives containing levonorgestrel and ethinyl estradiol.
Warfarin
- Although it was predicted that co-administration of
intravenous Akynzeo with warfarin would not substantially increase the systemic
exposure to S-warfarin (CYP2C9 substrate), the active enantiomer, the effects
of Akynzeo for injection and Akynzeo capsules on INR and prothrombin time have
not been studied. - Monitor INR and adjust the dosage of warfarin, as needed with
concomitant use of Akynzeo, to maintain the target INR range.
Effects Of Other Drugs On Akynzeo
- Netupitant is mainly metabolized by CYP3A4.
- Palonosetron is mainly metabolized by CYP2D6 and to a
lesser extent by CYP3A4 and CYP1A2.
CYP3A4 Inducers
Avoid concomitant use of Akynzeo in patients who are chronically using a
strong CYP3A4 inducer such as rifampin. A strong CYP3A inducer can decrease the
efficacy of Akynzeo by substantially reducing plasma concentrations of the
netupitant component.
CYP3A4 Inhibitors
- Concomitant use of Akynzeo with a strong CYP3A4 inhibitor (e.g.,
ketoconazole) can increase the systemic exposure to the netupitant component
of Akynzeo. - However, no dosage adjustment is necessary for single dose
administration of Akynzeo.
Serotonergic Drugs
- Serotonin syndrome (including altered mental status, autonomic
instability, and neuromuscular symptoms) has been described following the
concomitant use of 5-HT3 receptor antagonists and other serotonergic drugs,
including selective serotonin reuptake inhibitors (SSRIs) and serotonin and
noradrenaline reuptake inhibitors (SNRIs). - If symptoms occur, discontinue Akynzeo and initiate supportive
treatment.
Is Akynzeo safe to use while pregnant or breastfeeding?
- Limited available data with Akynzeo use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes.
- There are no data on the presence of netupitant (or fosnetupitant) or palonosetron in human milk, the effects on the breastfed infant, or the effects on milk production.
- The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for
Akynzeo and any potential adverse effect on the breastfed child from Akynzeo or from the underlying maternal condition.