Return of thalidomide: hospital dispensing to treat a type of myeloma

On February 2,

will begin to be marketed for the first time in Spain , a drug with an

that caused some 12,000 children to be born with serious congenital malformations between the late 1950s and early 1960s.

For this reason, the Spanish Agency for Medicines and Health Products (Aemps) has published a

this week on its website informing of the start of this commercialization (until now the

idomide was used for compassionate use and was accessed as a foreign medicine), its contraindication in pregnant women and the requirements that will be essential for its prescription and dispensing.

The presentation that will begin to be marketed in a few weeks will be

, being its only authorized indication, in combination with melphalan and prednisone, first-line treatment in patients with

65 years of age or older or unfit to receive high-dose chemotherapy.

In addition, it will be a medicine of

.

Along with this, and because of the risk of producing serious congenital malformations, the Aemps explains that in the European Union a series of requirements have been established for its prescription and dispensing with a

and a

whose objective is to avoid any exposure to thalidomide in pregnant women.

Said requirements will apply to any marketed medicinal product that contains this active principle.

Requirements of the Pregnancy Prevention Plan

Regarding the Pregnancy Prevention Plan, it is necessary to comply with a series of

to be able to use the drug, since it is contraindicated in pregnant women, as well as in women with childbearing capacity or men who do not meet certain conditions.

basic precautions

In fact, the Aemps security note details that the

They may only be treated with thalidomide if they meet the following requirements:

- Use of

without interruption as stipulated in the technical sheet.

- Realization of

before starting treatment, every four weeks during treatment and four weeks after the end of treatment.

- Comprehension

for the fetus in case of pregnancy, about other serious risks of treatment and the need to consult your doctor quickly if you think you may be pregnant.

As for the

, they will be informed of the

if they have sexual intercourse with a pregnant or potentially pregnant woman, "since thalidomide is excreted through semen, so it is necessary to use a condom throughout the treatment (including during periods of interruption of administration) and for at least seven days after completion.

Coupled with this, from the Aemps they emphasize that the prescriber "must ensure that patients

" to comply with the requirements of the Pregnancy Prevention Plan and that, for more detailed information, it is recommended to consult section 4.4

of the

drug data sheet

.

Request through the controlled access system

The Aemps also informs that the request for treatment with thalidomide will be made through the

of the agency, in which a specific form has been enabled with the requirements of the Controlled Access System.

In this way, when making an initial request for treatment, the following must be provided:

, the

and the

(woman with/without childbearing capacity or man);

and a

completed and signed by both the medical professional (who ensures that he has explained the details of this treatment and its associated risks), and by the patient (who confirms that he understands and agrees to comply with the requirements of the Pregnancy Prevention Plan, giving consent to start treatment).

In the security note that it has published, Aemps emphasizes that both the

data sheet

and the

prospect

, As the

material on risk prevention

of thalidomide, are found

on the website of the CIMA of the Aemps.

In addition, it recalls "the importance of notifying all suspected adverse reactions of medicines for human use to the

regional pharmacovigilance center

corresponding or through the electronic form available at

".

To continue reading for free

Sign inSign up for free

Or

and you will have access to all the web content of El Mundo