ADLUMIZ (Anamorelin) in Cancer Cachexia Management

ADLUMIZ (Anamorelin) in Cancer Cachexia Management

• May 7, 2021
• Reading time: 2 minutes

Following our previous announcement regarding the commercial launch of ADLUMIZ in Japan, we have received numerous inquiries from patients and medical professionals. This article provides a comprehensive summary of the indications, contraindications, and safety profile of ADLUMIZ.

Indications (Eligible Patients): ADLUMIZ is indicated for patients meeting the following criteria:

1. Advanced or recurrent non-small cell lung cancer (NSCLC), gastric cancer, pancreatic cancer, or colorectal cancer that is unresectable.
2. Patients experiencing cancer cachexia where nutritional therapy has shown limited efficacy.
3. Patients with unexplained weight loss of more than 5% within the past six months and loss of appetite, accompanied by at least two of the following:
   • Persistent fatigue or malaise.
   • Generalized weakness.
   • Laboratory findings including CRP > 0.5 mg/dL, Hemoglobin < 12 g/dL, or Albumin < 3.2 g/dL.

Contraindications (Patients who should not use this medication):

1. Patients with a known hypersensitivity to Anamorelin Hydrochloride or any components of the drug.
2. Patients with congestive heart failure (risk of exacerbation due to suppressed cardiac function).
3. Patients with myocardial infarction or angina pectoris.
4. Patients with cardiac conduction disorders (ADLUMIZ has sodium channel inhibitory effects, which may impair cardiac conduction).
5. Patients currently taking medications including: Clarithromycin, Indinavir, Itraconazole, Nelfinavir, Saquinavir, Telaprevir, Voriconazole, or medications containing Ritonavir or Cobicistat.
6. Patients with moderate to severe hepatic impairment (Child-Pugh Class B or C), as the drug is primarily metabolized by the liver, potentially leading to increased blood concentration and impaired cardiac conduction.
7. Patients with intestinal obstruction or organic lesions that make oral intake difficult.

Side Effects: In Phase 2 and Phase 3 clinical trials conducted in Japan (ONO-7643-03, 04, and 05), 84 out of 187 patients (44.9%) experienced adverse events. The most frequent side effects included increased gamma-GTP (6.4%) and increased HbA1c (5.9%). Serious adverse events included cardiac conduction system abnormalities (10.7%), hyperglycemia (4.3%), exacerbation of diabetes (4.3%), and liver dysfunction (6.4%).

Important Note: ADLUMIZ is a prescription medication. It must only be used under the direct supervision and prescription of a qualified physician.

Source: Ono Pharmaceutical - Oncology Reports.

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