Alternate dosage formulations of oral targeted anticancer agents

Abstract

Objective Oral anticancer therapies have demonstrated superior outcomes compared to traditional cytotoxic chemotherapy in many disease states. However, certain patients may not be candidates for these agents due to odynphagia or dysphagia. The purpose of this review is to summarize the data for extemporaneous compounding of oral anticancer agents. Data sources Food and drug administration approvals of oncology agents were reviewed to identify oral anticancer therapies. In order to find alternative administration options: the package inserts of each of these agents were reviewed, each medication was searched in a tertiary drug information resource, the medical information teams of each drug manufacturer were contacted to inquire about proprietary data, sites with pediatric trials were contacted, a primary literature search was performed, and listservs for national pharmacy and oncology organizations were reviewed. Data summary Eighty-five food and drug administration-approved oral anticancer therapies were identified to be included. Of those agents, nine (11%), had information in the package insert related to alternative administration. After further research, 46 (54%) of the agents had some information related to alternate formulations for administration. The recipes and stability of each of these compounds is included. Conclusions The majority of agents do not have Phase I or II trials that assess safety or pharmacokinetics of alternative formulations. Clinicians should exercise caution when recommending or administering these agents outside of food and drug administration-approved indicated use and utilize clinical judgment in assessing the risks and benefits of altering anticancer compounds. However, the alternative administration considerations presented can increase access to oncology patients who have difficulty swallowing.

Preparation of extemporaneous solutions with chemotherapeutic agents for pediatric patients: Ensuring safe and effective treatment

“…The preparation of extemporaneous solutions of chemotherapy agents requires good handling practices, linked to the scientific basis of the pharmacotechnical feasibility of handling the medication without altering its pharmacological properties. In this sense, several studies 6,13,23,24 were verified, which compiled data on these adjustments and others that report clinical cases presenting the possibility of adapting pharmaceutical forms for pediatric oncology patients.…”

Efficacy and toxicity of vemurafenib and cobimetinib in relation to plasma concentrations, after administration via feeding tube in patients with BRAF-mutated thyroid cancer: a case series and review of literature

“…In other types of cancer, several reports have been published on the efficacy of different oral targeted anti-cancer agents, including tyrosine kinase inhibitors (TKIs), when administered via a feeding tube. However, the majority of the available data on alternative administration routes comprises single case reports [ 19 – 22 ]. Moreover, only a few prospective studies focused on the bioavailability of these compounds when administered via a nasogastric or PEG tube.…”

Evaluation of the type and frequency of extemporaneous formulations dispensed in hospital and community pharmacies

“…3 Although commercially available medicines meet the therapeutic needs of most patients, lack of appropriate dosage forms, doses or strengths for certain patient groups is not uncommon. 4 , 5 , 6 , 7 , 8 Notably, extemporaneously compounded medications are more frequently required in the pharmaceutical care of paediatric and geriatric patients. In the case of paediatric patients, licensed formulations may be unavailable.…”