ELADYNOS Solution for injection Ref.[51680] Active ingredients: Abaloparatide

Posology

The recommended dose is 80 micrograms once daily.

The maximum total duration of treatment with abaloparatide should be 18 months (see sections 4.4 and 5.1).

Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate.

Following cessation of abaloparatide therapy, patients may be continued on other osteoporosis therapies such as bisphosphonates.

Missed dose

If a patient forgets or cannot administer their dose at the usual time, it can be injected within 12 hours of the normally scheduled time. Patients should not administer more than one injection in the same day and should not try to make up for a missed dose.

Special populations

Elderly patients

Dose adjustment based on age is not required (see section 5.2).

Renal impairment

Abaloparatide must not be used in patients with severe renal impairment including patients with end-stage renal disease (see section 4.3). In patients with mild to moderate renal impairment, dose-based adjustment is not required (see section 5.2).

Hepatic impairment

No data are available in patients with impaired hepatic function. Dose adjustment is not required for these patients, as it is unlikely that hepatic impairment will have a significant effect on abaloparatide exposure (see section 5.2).

Paediatric population

Abaloparatide should not be used in children and adolescents less than 18 years because of safety concerns (see section 5.3).

Method of administration

For subcutaneous use only.

The first injection(s) administered by the patient or caregiver should be performed under the guidance of an appropriately qualified health care professional (see section 4.4). Patients and/or caregivers should be trained in the subcutaneous administration of abaloparatide (see section 6.6). A detailed instruction for use is included in each pack to instruct patients on the correct use of the injection pen.

Abaloparatide should be injected in the lower abdomen. The site of the injection should be rotated every day. Injections should be administered at approximately the same time every day.

Signs and symptoms

In clinical trials, abaloparatide has been administered subcutaneously in single doses of up to 320 micrograms and in repeated doses of up to 120 micrograms/day for 7 days. The primary dose-limiting adverse effect was postural dizziness.

The effects of overdose that might be expected include transient hypecalciuria, hypercalcaemia, nausea, vomiting, dizziness, palpitations, orthostatic hypotension and headache.

In the clinical programme with an earlier pen design, accidental overdose was reported in a patient who received 400 micrograms in one day (5 times the recommended clinical dose). The patient experienced asthenia, headache, nausea, and vertigo. Serum calcium was not assessed on the day of the overdose, but on the following day the patient’s serum calcium was within the normal range.

Overdose management

There is no specific antidote for abaloparatide. Treatment of suspected overdose may include transitory discontinuation of treatment, monitoring of serum calcium and implementation of appropriate supportive measures, such as hydration.

3 years.

After first use or once removed from the refrigerator, store the pen below 25 °C. It must be used within 30 days.

Store in a refrigerator (2°C – 8°C). Do not freeze.

For storage conditions after the medicinal product is removed from the refrigerator, see section 6.3.

Cartridge (siliconised Type I glass) with a plunger (chlorobutyl rubber), crimp cap (bromobutyl rubber seal)/aluminium assembled into a disposable pen.

Eladynos is available in pack sizes of 1 or 3 pre-filled pens.

Each pre-filled pen contains 1.5 mL of solution (30 doses).

Not all pack sizes may be marketed.

Each pen should be used by only one patient. A new, sterile needle must be used for every injection. The pen should only be used with 8 mm, 31-gauge needles. No needles are supplied with the medicinal product. Do not store the pen with the needle attached.

Eladynos should not be used if the solution is cloudy, coloured or contains particles.

Before using the pen device for the first time, the patient should read and understand the instructions on how to use the pen. A detailed Instructions for Use is provided with the pen in the carton.

Injecting Eladynos

Step 1 Check the Eladynos pen:

• Before using the pen always check the label to be sure it is the correct pen.
• Make note of the date of Day 1 in the space provided on the carton. Do not use the pen for more than 30 consecutive days. Dispose of the pen 30 days after first use.
• Pull off the pen cap from the pen.
• Check the Eladynos cartridge. The liquid should be clear, colourless, and free of particles; if not, do not use. Small air bubbles may be present in the liquid; this is normal.

Step 2 Attach needle to the Eladynos pen:

• Remove the protective paper from a new needle.
• Push the capped needle straight onto the pen and twist until it is secure. Make sure the needle is straight so that it doesn’t bend when inserting. The pen will not work if the needle is not properly attached. Do not over-tighten as this may make the needle difficult to remove.
• Pull off the outer needle cap from the needle and keep it to use after the injection.
• Carefully pull off the inner needle cap and dispose of it. Step 3 Day 1 Only – Testing an Eladynos pen prior to first injection
• The pen has medicine for 30 days and a small amount to test each pen once, to confirm it is working properly.
• Attention: If the patient tests the pen before every injection, then the pen will run out of medicine early. Therefore, perform Step 3 once for each pen, only on Day 1, prior to first injection.
• For Day 2 through Day 30, do not test the pen again, go directly to Step 4 to set the dose for the injection.
• Turn the dose knob on the pen away from you (clockwise) until it stops. “•80” will be lined up in the dose display window.
• Hold the pen with the pen needle pointing up.
• Press the green injection button until it will not go any further. Liquid, as a drop or stream, come out of the needle tip. If no liquid appears, see Troubleshooting in the “Instructions for use” at the end of the package leaflet. “●0” will be lined up in the dose display window.

Step 4 Set the dose on the Eladynos pen:

• Turn the white knob on the pen away from you (clockwise) until the knob stops and “●80” is lined up in the display window. The pen is now ready for injection.

Step 5 Choose and clean the injection site:

• Injections should be given in the lower abdomen. Avoid the 5 cm area around your belly button (navel).
• For each injection, select a different injection site on the abdomen each day. Only inject into clear skin. Do not inject into areas on the abdomen where the skin is tender, bruised, red, scaly, or hard. Avoid areas with scars or stretch marks.
• Wipe the injection site with an alcohol swab and allow it to dry.
• Do not touch, fan, or blow on the injection site after it has been cleaned.
• Note: It may be recommended to pinch up the skin at the site where the injection will occur. Once the needle enters the skin, the pinch can be released.

Step 6 Giving your Eladynos pen injection:

• Insert the needle straight into your skin.
• Press and HOLD the green button until ALL events below are complete and “●0” is displayed.
• Hold for 10 seconds to give full dose, withdraw pen from skin, and THEN release the button.

Step 7 Remove the pen needle:

• Carefully place the outer needle cap back on the needle. Then carefully press on the outer needle cap until it snaps into place and is secure.
• Unscrew the capped needle (like unscrewing a cap from a bottle). To unscrew the capped needle, squeeze the cap at the base against the needle and turn it 8 or more turns and then gently pull until the capped needle comes off.
• Note: Do not push down on the outer needle cap while unscrewing the needle.
• Note: You should see a gap widening between the outer needle cap and the pen as you unscrew the needle.

Step 8 After your injection:

• Firmly replace the pen cap onto the pen.
• Keep the pen cap on your Eladynos pen between injections.
• The patient may have slight bleeding, this is normal. Do not rub the injection site. If slight bleeding occurs, press a cotton ball or gauze pad as needed to stop the bleeding. The patient may also cover the injection site with a small adhesive bandage.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.