NORDITROPIN HGH FLEX PEN

Norditropin HgH 10 mg flex pen

Norditropin^® has been FDA-approved in the United States since 1995. Find quick facts about our history, milestones, and our commitment to the growth hormone therapy community.

The HgH pens contain 100% bio-identical 191 amino acid chain human growth hormone.

10mg is 30iu’s of gh – growth hormone (somatropin) – , (3iu = 1mg of gh – growth hormone (somatropin) – , approximately)

Read the Patient Information that comes with Norditropin before you start to take it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What is Norditropin?

Norditropin is a prescription medicine given by injection under the skin (subcutaneous) that contains human growth hormone, identical to the growth hormone produced in the human body, used to treat:

children who are not growing because of low or no growth hormone
children who are short (in stature) and who have Noonan syndrome or Turner syndrome
children who are short (in stature) because they were born small (small for gestational age-SGA) and have not caught-up in growth by age 2 to 4 years
adults who do not make enough growth hormone

Who should not use Norditropin?

Do not use Norditropin if:

you have a critical illness caused by certain types of heart or stomach surgery, trauma or breathing (respiratory) problems
you are a child with Prader-Willi syndrome who is severely obese or has breathing problems including sleep apnea
you have cancer or other tumors
your healthcare provider tells you that you have certain types of eye problems caused by diabetes
you are a child with closed bone growth plates (epiphyses)
you are allergic to any of the ingredients in Norditropin. See the end of this leaflet for a complete list of ingredients in Norditropin.

What should I tell my healthcare provider before I start Norditropin?

Before you take Norditropin, tell your healthcare provider if you:

have diabetes
had cancer or any tumor
have any other medical condition
are pregnant or plan to become pregnant. It is not known if Norditropin will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
are breast-feeding or plan to breast-feed. It is not known if Norditropin passes into your breast milk. You and your healthcare provider should decide if you will take Norditropin while you breast-feed.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Norditropin may affect how other medicines work, and other medicines may affect how Norditropin works.

Especially tell your healthcare provider if you take:

glucocorticoid medication
thyroid hormone
insulin or other medicine for diabetes
medicines that are metabolized by the liver
estrogen replacement medicines

Ask your healthcare provider if you are not sure if any of your medicines are the kind listed above. Keep a list of your medicines with you and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I use Norditropin?

Read the detailed Instructions for Use that come with Norditropin. Your healthcare provider will show you how to inject Norditropin.
Take Norditropin exactly as prescribed.
Norditropin FlexPro pens, NordiFlex pens and cartridges are for use by one person only.
Novo Nordisk disposable needles are designed to be used with Norditropin for each injection.
Always keep the pen cap closed on Norditropin when you are not using it.
If you inject too much Norditropin, call your healthcare provider.
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose. Just take the next dose at your regular time. Do not take 2 doses at the same time unless your healthcare provider tells you to. If you are not sure about your dosing, call your healthcare provider.
Throw away Norditropin when the cartridge is empty.
Refer to the Instructions for Use about what to do if you have less than a full dose left in your pen.

What are the possible side effects of Norditropin?

Norditropin can cause serious side effects, including:

high risk of death in people who have critical illnesses because of heart or stomach surgery, trauma or serious breathing (respiratory) problems
high risk of death in children with Prader-Willi syndrome who are severely obese or have breathing problems, including sleep apnea
return of tumor or cancerous growths
high blood sugar (hyperglycemia)
increase in pressure in the skull (intracranial hypertension). If you have headaches, eye problems, nausea or vomiting, contact your healthcare provider right away.
swollen hands and feet due to fluid retention
decrease in thyroid hormone levels. Your healthcare provider will do blood tests to check your thyroid hormone levels.
hip and knee pain or a limp in children (slipped capital femoral epiphysis)
worsening of curvature of the spine (scoliosis)
middle ear infection, hearing problems or ear problems in patients with Turner syndrome
redness, itching and tissue weakness in the area you inject
increase in phosphorus, alkaline phosphatase and parathyroid hormone levels in your blood. Your healthcare provider will do blood tests to check this.

The most common side effects of Norditropin include:

headaches
muscle pain
joint stiffness
high blood sugar (hyperglycemia)
sugar in your urine (glucosuria)
swollen hands and feet due to fluid retention
redness and itching in the area you inject

Talk to your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Norditropin. For more information, ask your healthcare provider or pharmacist.

How do I store Norditropin?

Unused NordiFlex pens, and cartridges:

Keep in a refrigerator between 36ºF to 46ºF (2ºC to 8ºC).
Do not freeze or expose Norditropin to heat.
Keep Norditropin away from direct light.
Do not use Norditropin that has been frozen or in temperatures warmer than 77ºF (25ºC).
Do not use Norditropin after the expiration date printed on the carton and the pen or cartridge.

After the first injection

Norditropin FlexPro and NordiFlex 10 mg/ 1.5mL (blue):
- either store in the refrigerator between 36ºF to 46ºF (2ºC to 8º C) and use within 4 weeks.
- or keep for up to 3 weeks at no warmer than 77 ºF (25ºC).
- Throw away any unused medicine.

General Information about Norditropin.

Medicines are sometimes prescribed for purposes other than those listed in Patient Information. Do not use Norditropin for a condition for which it was not prescribed. Do not give Norditropin to other people, even if they have the same symptoms that you have. It may harm them.

This Patient Information summarizes the most important information about Norditropin. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Norditropin that is written for healthcare professionals.

What are the ingredients in Norditropin?

Active ingredient: somatropin (rDNA origin)

Inactive ingredients: Histidine, Poloxamer 188, Phenol, Mannitol, HCl/NaOH (as needed) and Water for Injection

US Patent Nos. 6,235,004; 6,004,297; 6,582,404; 6,716,198; 6,899,699; 5,849,704; 5,691,169; 5,618,697 and other patents pending.

Manufactured by: Novo Nordisk A/S

DK-2880 Bagsvaerd, Denmark