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Answers to frequently asked questions about the Nutropin AQ Pen 10

Questions regarding Nutropin AQ Pen 10 needles

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What if medication is leaking from the needle?

A: If the dose knob is turned past the maximum dose of 4.0 mg for the Nutropin AQ Pen 10, medication will come out of the needle. This could also occur if the plunger is not fully retracted prior to replacing a cartridge.

Does the needle need to be changed every time I use the Nutropin AQ Pen 10?

A: Yes. A new needle must be used for every injection. The needle is sterile only on first use.

What should be done with the needles after an injection is given?

A: The patient/caregiver should dispose of needles in a proper sharps disposal container. Improper disposal of needles and other medical sharps can cause needle-stick injuries, especially for garbage collectors. Advise patients to throw used needles away safely. Needles, sharps, or sharps containers should not be included in household trash. Collection programs for these items are available in many locations throughout the country. The specialty pharmacy (SP) or local health department may also be able to advise patients on disposal of containers.

The Coalition for Safe Community Needle Disposal is a coalition of businesses, community groups, nonprofit organizations, and the government that promotes public awareness and solutions for safe disposal of needles, syringes, and other sharps in the community. The Coalition website provides a searchable database of locations that accept used sharps. Patients can search for locations by visiting www.safeneedledisposal.org/.

Please see additional information about proper needle disposal and how to travel with GH medication.

Is there a specific needle recommendation for the Nutropin AQ Pen 10?

A: It is important to select a needle specific to each patient to enable delivery of growth hormone (GH) to the subcutaneous layer of the skin. The Nutropin AQ Pen 10 kit comes with the BD Ultra-Fine™ Original Pen Needle 29 gauge, 12.7 mm (1/2"). This size enables the needle to get to the correct depth of the subcutaneous tissue and also offers a wide inner diameter so that it’s easier to press the black dose knob and expel medication. To avoid the risk of injecting into muscle, injection technique is important, and a gentle pinch of the skin is required when inserting the needle.

Can the Nutropin AQ Pen 10 be used without the shields?

A: Yes. The Nutropin AQ Pen 10 is fully functional without the shields. The shields are optional to help patients administer their injections.

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Questions regarding Nutropin AQ Pen 10 cartridges

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Can the Nutropin AQ Pen 10 mg Cartridge be used in the Nutropin AQ Pen 20, and vice versa?

A: No. Even though either cartridge will fit in either pen, the Nutropin AQ Pen 10 mg Cartridge must be used with the Nutropin AQ Pen 10. The Nutropin AQ Pen 20 mg Cartridge must be used with the Nutropin AQ Pen 20. Remind patients to always match their prescribed strength Nutropin AQ Pen Cartridge (10 mg or 20 mg) with the corresponding Pen for that cartridge. Using the wrong cartridge in a pen will cause error in the dose that is delivered to the patient.

How long can the Nutropin AQ Pen 10 and Cartridge stay outside the refrigerator?

A: During use, it is recommended to keep Nutropin products outside of the refrigerator for no longer than 1 hour per day. If Nutropin products are kept outside the refrigerator for longer than one hour, the medication should not be used. Direct patients to call 1 (866) NUTROPIN for additional assistance. When traveling, instruct patients to keep their Nutropin device dry and stored within the appropriate temperature range 2^°-8^°C (36^°-46^°F).

What is the maximum dose the Nutropin AQ Pen 10 can deliver in 1 injection?

A: The maximum dose that may be delivered in 1 injection is 4.0 mg for the Nutropin AQ Pen 10. If a patient attempts to dose more than the maximum dose at one time, the drug will either be forced out of the needle and wasted or excess pressure will be placed upon the cartridge.

What if the cartridge window shows an amount that is less than expected or if it seems that excessive medication was wasted in the priming step?

A: The Nutropin AQ Pen 10 is designed to deliver 10 mg in 0.1 mg increments. However, the cartridge window is not exact in its markings. You may be able to help patients anticipate when, at their current dose, the cartridge will be completely used. For example, a 1.0 mg dose in a 10 mg cartridge/pen will deliver 10 doses.

What should be done if there is not enough medication left in the cartridge for a patient's dosing requirements?

A: This should be discussed with the patient's prescriber. He or she may want the patient to administer a partial dose with the medication left in the existing cartridge, then start a new cartridge and administer the remainder of the dose. Or, discard the amount that was not given.

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Questions regarding proper storage and maintenance of the Nutropin AQ Pen 10

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Where should the Nutropin AQ Pen 10 be stored?

A: A Nutropin AQ Pen 10 should be stored in its case, inside a refrigerator at 2°-8°C (36°-46°F), when a cartridge is inserted. When traveling, the pen case should be stored within the same temperature range. The pen must be KEPT DRY and free from moisture. DO NOT FREEZE.

Nutropin AQ is light sensitive and the vial, cartridges, and Nutropin AQ should be protected from light. Store the vial, cartridges, and Nutropin AQ injection device refrigerated in a dark place when they are not in use.

Why must the medication be kept in the refrigerator?

A: To maintain the potency of Nutropin AQ.

Can the Nutropin AQ Pen 10 be placed in the freezer?

A: No. Freezing will damage the pen and drug.

Is the Nutropin AQ Pen 10 waterproof?

A: No. Exposure to moisture may cause the digital dose display of the Nutropin AQ Pen 10 to malfunction. Do not immerse the Nutropin AQ Pen 10 in water. If the Nutropin AQ Pen 10 is accidentally immersed, remove it from the water and dry it immediately.

How do patients replace their Nutropin AQ Pen 10?

A: The patient needs to call their specialty pharmacy (SP). The SP may need to call the prescriber to authorize a prescription for the pen. If the patient has difficulty with the SP, the Nutropin Hotline number should be called.

What should patients do if they drop the Nutropin AQ Pen 10?

A: If patients drop their Nutropin AQ Pen 10, they should check to see if the cartridge is damaged. They should also check the pen to see that the black dose knob is moving up and down properly and that the digital dose display counter is working. If the pen or cartridge is damaged, the patient should receive a replacement pen.

How long can patients use the Nutropin AQ Pen 10?

A: The Nutropin AQ Pen 10 has a battery that is designed to last approximately 24 months from the time of first use. If patients have a functionality issue with the Pen, direct them to call 1-866-NUTROPIN for additional assistance.

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Questions regarding the black dose knob of the Nutropin AQ Pen 10

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What if the black dose knob cannot be depressed?

A: A dose must be dialed for the knob to be depressed. The most common reason the black knob cannot be depressed is that the knob may be between clicks. Try turning the dosing knob forward until it clicks into dosing position. If this problem happens when the last dose in the cartridge is dialed, turn the knob backward until it clicks into dosing position. The dosing knob cannot be depressed if the needle is not screwed on properly or is bent or occluded. Remind patients to inspect the needle and change it, if necessary.

Is it possible to turn the black dose knob back if it is dialed past the intended dose?

A: Yes. The black dose knob can be turned backward until the correct number appears in the digital dose display.

Why do I have to rewind the black dose knob on the Nutropin AQ Pen 10 every time a cartridge is replaced?

A: This ensures that the plunger push rod completely resets itself back to the starting position. If this is not done, liquid will come out of the needle when a new cartridge is placed into the pen.

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Questions regarding the digital dose display of the Nutropin AQ Pen 10

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What does "bt" (blinking or steady) mean in the digital dose display?

A: The battery in the Nutropin AQ Pen 10 is losing its charge. At this time, patients should receive a replacement pen. Batteries typically last 24 months and have a 4-week life from the time the "bt" first appears.

What does it mean when either 3 or 6 bars flash or appear steady on the digital dose display?

A: When this occurs, it means this pen has been used for 2 years and should be replaced. A Nutropin AQ Pen 10 has 4 weeks of life remaining from the time that the flashing bars first appear. At this time, patients should receive a replacement pen.

How does the dose recall function work?

A: Wait at least 2 minutes after the previous injection before pressing the white reset button. The last dose injected will flash in the digital dose display for 5 seconds when the white reset button is depressed, then 0.0 appears.

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Questions regarding Nutropin AQ Pen 10 injection safety

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What sites should the patient use for injection?

A: The medication should be given subcutaneously as ordered by the prescriber. Suggested injection sites include the back of the upper arms, upper thighs, upper buttocks, and abdomen. It's important that patients alternate injection sites to minimize tissue atrophy (or wasting).

Why is it important to rotate injection sites?

A: Injection site discomfort has been reported. It's important that patients rotate the injection site to avoid tissue atrophy that may result from subcutaneous administration of GH at the same site over a long period of time.

What are the most common adverse events?

A: The most common adverse event is an injection site reaction. Other adverse events may include mild, transient peripheral edema, arthralgias, scoliosis, changes in vision, headache, nausea, carpal tunnel syndrome, and allergic reactions.

Who should the patient contact if he or she experiences a side effect or adverse event?

A: If a patient experiences side effects or an adverse event, instruct them to call the healthcare professional (HCP). They are also encouraged to report this information to the FDA at 1-800-FDA-1088.

If the HCP receives information from a patient that indicates he or she is experiencing an adverse event, what should be done?

A: If the HCP becomes aware of a patient having an adverse event, he or she should call the FDA at 1-800-FDA-1088 or contact Genentech Drug Safety/Adverse Events at 1-888-835-2555.

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