Updates

Two batches of Targocid 200mg powder recalled

The batches shown in Table 1 of Targocid 200 mg powder for injection/infusion or oral solution are being recalled immediately by Sanofi UK. This is due to out of specification results for bacterial endotoxins, as confirmed by testing of retain samples. This problem was discovered after a medical adverse event in which four patients developed a high grade of fever within three hours of receiving vials from the impacted batches.

There is a potential life-threatening or serious risk to patient health as a result of the out-of-spec results observed.

Medical professionals should be aware of the following symptoms if they arise: A high temperature (fever) or low body temperature, chills and shivering, cold, clammy and pale or mottled skin, a fast heartbeat, fast breathing, severe breathlessness, severe muscle pain, feeling dizzy or faint, a change in mental state - such as confusion or disorientation, loss of consciousness, slurred speech, nausea and vomiting and/or diarrhoea, nausea and vomiting and/or diarrhoea.

If the affected batches have been administered to patients, an appropriate clinical assessment, as well as close monitoring for any adverse reactions, should be performed. All suspected adverse events should be reported immediately to the MHRA's Yellow Card scheme.

Pharmacists should immediately stop supplying the batches shown in Table 1, quarantining all the remaining stock and returning it to your supplier using your supplier's approved process.

It should immediately be identified whether your organisation has supplied the affected batches to patients for home use. If the batch traceability isn't available, identify any patients dispensed this product since 28 July 2022.

Patients should be asked to return the impacted batches for disposal.

Any patients impacted should be contacted to help them source alternatives, including ensuring a new prescription is available for the patient when they return their medication to the pharmacy.

Palbociclib with fulvestrant for treating hormone receptor-positive, HER2-negative advanced breast cancer after endocrine therapy

A recent National Institute for Health and Care Excellence (NICE) appraisal has released guidance recommending palbociclib plus fulvestrant as a treatment option for adults with hormone receptor-positive, HER2negative locally advanced or metastatic breast cancer who have received endocrine therapy if:

• Exemestane in combination with everolimus is the best alternative to a cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor
• It is provided by the company per the commercial arrangement.

If patients and their clinicians believe that palbociclib plus fulvestrant, abemaciclib plus fulvestrant, or ribociclib plus fulvestrant are appropriate options, choose the least expensive. Consider the costs of monitoring and adverse events, as well as the dosage, price per dose, and commercial arrangements.

The evidence for palbociclib plus fulvestrant for hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer after endocrine therapy is reviewed in the NICE technology appraisal guidance, TA619. It also examines new evidence from a clinical trial as well as data gathered from people receiving treatment under the Cancer Drugs Fund managed access agreement. Palbociclib plus fulvestrant is clinically effective, according to new evidence gathered from people receiving treatment through the Cancer Drugs Fund. Additional clinical trial evidence suggests that it extends people's lives when compared to placebo plus fulvestrant.

Indirect comparisons indicate that it has clinical efficacy comparable to abemaciclib plus fulvestrant and ribociclib plus fulvestrant. According to a cost comparison, palbociclib plus fulvestrant is comparable to abemaciclib plus fulvestrant and ribociclib plus fulvestrant. If palbociclib plus fulvestrant is used in the same population as abemaciclib and ribociclib, it is recommended.