Aphexda(motixafortide)

Aphexda is an innovative CXCR4 inhibitor which contains 62mg of motixafortide administered by subcutaneous injection.

[Indications for Aphexda(motixafortide)]
Aphexda is indicated for use in combination with filgrastim (G-CSF) to mobilise haematopoietic stem cells into the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma.

[Aphexda (motixafortide) Usage and Dosage]
1. Aphexda therapy is initiated after filgrastim has been injected and is administered daily for 4 days.
2. The recommended dose is 1.25 mg/kg of actual body weight, administered subcutaneously 10 to 14 hours before starting.
3. The second dose of Aphexda may be administered 10 to 14 hours later, prior to the third single dose.
See full prescribing information for preparation instructions and administration.

[Contraindications to Aphexda (motixafortide)]
Aphexda is contraindicated in patients with a history of severe allergic reactions to motixafortide.

[Aphexda (motixafortide) warnings and precautions]
Anaphylaxis and allergic reactions
Anaphylaxis and allergic reactions occur. Preoperative dosing Approximately 30-60 minutes prior to each administration of Aphexda, a triple dosing regimen consisting of an H1 antihistamine, an H2 blocker, and a leukotriene inhibitor was used in all patients. Administer Aphexda in a setting where personnel and treatments are immediately available to treat allergic and other systemic reactions Monitor patients for 1 hour after Aphexda administration and treat reactions promptly. Patients receiving negative chronotropic drugs (e.g., beta-blockers) may be more susceptible to hypotension in the setting of an anaphylactic reaction, and these drugs should be replaced with non-chronotropic drugs when appropriate.
②Injection site reactions
Injection site reactions occurred (73%) and included pain (53%), erythema (27%), and pruritus (24%).Serious reactions occurred in 9% of patients. Take an analgesic medication (e.g., acetaminophen) before each use of Aphexda. Use analgesic medications and topical treatments after administration as needed.
(iii) Tumour cell mobilisation in leukaemia patients
In order to mobilise haematopoietic stem cells (HSC), Aphexda may mobilise leukaemia cells and subsequently contaminate the monoclonal product. Therefore, Aphexda is not indicated for HSC mobilisation and collection in leukaemia patients.
④ Leukocytosis
Co-administration of Aphexda with filgrastim may increase the number of circulating leukocytes and HSC.Monitor leukocyte counts during Aphexda administration.
⑤ Potential for tumour cell mobilisation
When Aphexda is used in combination with filgrastim for HSC mobilisation, tumour cells may be released from the bone marrow and subsequently collected in leukocyte isolation products. The effect of potential transfusion of tumour cells back into the bone marrow has not been well studied.
vi Embryo-fetal toxicity
Based on its mechanism of action, Aphexda can cause foetal damage. Inform pregnant women of the potential risk to the foetus. Prior to initiating treatment with Aphexda, verify the pregnancy status of females of reproductive potential and recommend the use of effective contraception during treatment and for 8 days after the last dose.

[Aphexda (motixafortide) in special populations]
1. Breastfeeding:There are no data on the presence of motixafortide in breast milk, effects on breastfed infants, or effects on milk production. Breast-feeding is not recommended for women during treatment with Aphexda and for 8 days after the last dose.
2.Paediatric Use:The safety and efficacy of Aphexda in paediatric patients have not been established.
3.Pregnancy:Based on its mechanism of action, Aphexda can cause fetal damage. Inform pregnant women of the potential risk to the fetus.

[Aphexda (motixafortide) Adverse Reactions].
The most common adverse reactions (incidence > 20%) in patients treated with Aphexda were injection site reactions [73%, including pain (53%), erythema (27%), and pruritus (24%)]; pruritus (38%); flushing (33%); and back pain (21%).