Dosage and Administration

The recommended dose of QosequTM (denosumab) is a single SC injection of 60 mg, once every 6 months.

 

Administration of QosequTM should be performed by an individual who has been adequately trained in injection techniques.

Dosage1

QosequTM is intended for use under the guidance and supervision of physicians who have fully familiarized themselves with the efficacy/safety profile of QosequTM.

After an initial training in proper subcutaneous injection technique, patients may self-inject QosequTM if a physician determines that is appropriate and with medical follow-up as necessary. Patients should be informed that serious hypersensitivity reactions, including anaphylaxis, have been reported with denosumab injections.

Pregnancy must be ruled out prior to administration of QosequTM.

Perform pregnancy testing in all women of reproductive potential prior to administration of QosequTM. Based on findings in animals, denosumab may cause fetal harm when administered to pregnant women.

Patients must be adequately supplemented with calcium and vitamin D at the recommended doses.

There is no experience with overdosage with denosumab. For management of a suspected drug overdose, contact your regional poison control centre.

 

Missed Dose1

If a dose is missed, it should be given as soon as convenient. The next dose should be scheduled 6 months from the date of the previous injection.

To avoid missing a dose, QosequTM is provided with a reminder card, available as a peel off sticker on the syringe tray. When getting the QosequTM injection, the patient can remove the reminder card from the syringe tray, write the date of the next dose (i.e., 6 months later), and keep the reminder card somewhere safe.

Administration1

Administration of QosequTM should be performed by an individual who has been adequately trained in injection techniques. The prefilled syringe is not made with natural rubber latex.

Instructions for administration

Administer QosequTM via SC injection in the upper arm, the upper thigh, or the abdomen.

Please click here to view the QosequTM self-injection instructions for patients and watch the self-injection video below.

Administration1

  • Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration, whenever solution and container permit.
  • Prior to administration, QosequTM may be allowed to be removed from the refrigerator for approximately 30 minutes in order to reach room temperature (up to 25°C), in the original container.
  • QosequTM is a sterile, preservative-free, clear, colorless to pale yellow solution, formulated at pH 5.2.
  • QosequTM is supplied in a single use prefilled syringe with an automatic needle guard. The prefilled syringe is not made with natural rubber latex.
  • Each 1.0 mL single use prefilled syringe of QosequTM contains 60 mg denosumab, 46 mg sorbitol, 1.08 mg glacial acetic acid, 0.1 mg polysorbate 20, water for injection, and sodium hydroxide to a pH of 5.2.
  • QosequTM is supplied in a dispensing pack containing one prefilled syringe.