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Manufacturer’s response to letter about ‘Sayana Press and a case of likely lipoatrophy’
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  1. Seema Patel
  1. Correspondence to Seema Patel, Pfizer Essential Health UK, Pfizer Limited, Tadworth, Surrey KT20 7NS, UK; seema.s.patel{at}pfizer.com

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Pfizer would like to acknowledge the case study titled ‘Sayana Press and a case of likely lipoatrophy’1 published online in BMJ Sexual & Reproductive Health in June 2018.

Sayana Press (medroxyprogesterone acetate) is indicated for long-term female contraception and may be administered by a healthcare professional (HCP) or, when considered appropriate by the HCP, self-injected by the patient, with medical follow up as necessary in accordance with local clinical guidance. Each subcutaneous injection prevents ovulation and provides contraception for at least 13 weeks (+/– 1 week).2

The Sayana Press Summary of Product Characteristics states under ‘Section 4.8 Undesirable effects’ that injection-site reactions such as persistent injection-site atrophy/indentation/dimpling, injection-site nodule/lump and injection-site pain/tenderness are commonly reported (occurring in ≥ 1/100 to <1/10) and lipodystrophy (acquired) is rarely reported (occurring in ≥ 1/10 000 to <1/1000) in patients receiving subcutaneous depot medroxyprogesterone acetate (DMPA-SC).2

In clinical studies that enrolled 2053 women who received DMPA-SC for contraception, injection-site reactions (any type) were reported in 6.1% of the participants. Approximately half were reported at the time of the first injection. Some subjects had multiple occurrences of the same adverse event and/or had more than one type of injection-site reaction. Most were transient events and of mild intensity; few subjects (0.5%, 11/2043) withdrew from study participation because of an injection-site reaction. The incidences of injection-site reactions (by composite term, with one or more occurrences per subject) were injection-site nodule/lump (1.9%, 38/2043), injection-site atrophy/dimpling (1.5%, 30/2043), injection-site pain/tenderness (1.4%, 28/2043) and injection-site reaction general (1.4%, 28/2043). None was classified as serious.3

Cameron et al 4 reported on the results of a pilot study of self-administration of DMPA-SC among existing users of intravenous DMPA (DMPA-IM) who wished to self-inject (n=64). The main outcome was the continuation rate of the method at 12 months compared with a control group of existing users of DMPA-IM (n=64). The 12-month discontinuation rate of the DMPA-SC group (12%) did not differ significantly from that of the DMPA-IM group (22%) (p=0.23). All the women completed a questionnaire regarding their satisfaction with the method of administration, including any adverse events.3

Four women (6%) reported a localised acute reaction at the DMPA-SC injection site (redness, pruritus, bruising or blistering), which occurred after the first (n=2) or second subcutaneous injection (n=2). Six women (9%) reported having experienced a total of nine mild injection-site changes consisting of an area of atrophy (n=5), induration (n=3) or area of scarring (n=1). These appeared after the second DMPA-SC dose in five cases and after the third or fourth (final) injection for the remainder. Treatment was discontinued for the five women who developed these injection-site changes prior to the last study injection. By the close of the study, one patient reported resolution, two patients reported that the changes had almost resolved; two were reported as ongoing, and one woman was lost to follow-up. Overall, there was no significant difference in the proportion of women in either group who wished to continue the injectable method that they used during the study; 90% and 91%, respectively, for DMPA-SC and DMPA-IM.4

There are no definitive data to identify the mechanism of action associated with the lipoatrophy associated with DMPA-SC or other subcutaneous injections. Possible mechanisms proposed have included localised hypersensitivity or inflammatory reactions, or mechanical injury.

For further information regarding indications, dosage and administration, contraindications, warnings and precautions, interactions and adverse effects, please refer to the full prescribing information for Sayana Press.2

References

Footnotes

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests SP is the Medical Director at Pfizer Essential Health UK, the manufacturer of Sayana Press.

  • Patient consent Not required.

  • Provenance and peer review Commissioned; internally peer reviewed.

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