Parathyroid hormone (Subcutaneous)

Parathyroid hormone injection is used with calcium and vitamin D to manage hypocalcemia (low calcium levels) in patients with hypoparathyroidism. Hypoparathyroidism occurs when the parathyroid gland in the neck does not produce enough parathyroid hormone (PTH).

This medicine is only available through a restricted access program. Doctors who are part of the restricted program can prescribe this medicine.

It is important that your doctor check your progress at regular visits to ensure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Do not use this medicine together with alendronate (Fosamax®).

This medicine may increase your risk of having osteosarcoma (bone tumor). This is more likely to happen if you have Paget's disease of the bone, high levels of alkaline phosphatase, genetic disorders, children with open epiphyses, or a history of external beam or implant radiation therapy. Tell your doctor right away if you have bone pain that does not go away or a new soft tissue mass that is tender to touch.

Severe hypercalcemia (high calcium in the blood) may occur while using this medicine. This is more likely to happen when you start treatment or increase your dose. Call your doctor right away if you have confusion, constipation, dry mouth, metallic taste, muscle weakness, nausea or vomiting, or weight loss.

Do not stop using this medicine suddenly without asking your doctor. This may increase your risk of having severe hypocalcemia (low calcium in the blood). Symptoms include abdominal or stomach cramps, muscle spasms or twitching, numbness or tingling in your fingers, toes, or around your mouth, or trouble breathing.

Do not take other medicines unless they have been discussed with your doctor. Taking other medicines (especially digoxin, Lanoxin®) together with Natpara® may require your doctor to change the dose of one of the medicines.

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine compared to the benefits it may provide. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your health care professional know if you have other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not been done to determine how age affects the use of parathyroid hormone injection in children. Safety and effectiveness have not been established.

Geriatric

Current studies have not shown specific problems in elderly patients that would limit the usefulness of parathyroid hormone injection in older adults. However, older patients are more likely to have kidney issues, which may require caution and a dose adjustment for those using this medicine.

Breast Feeding

There are no adequate studies on the risks to infants when this medication is used by breastfeeding women. Weigh the potential benefits against the potential risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may want to adjust the dose or take other precautions. When taking this medicine, it is very important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions have been highlighted for their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you take one or both of the medicines.

• Alendronate

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with some medicines can also cause interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect the use of this medicine. Be sure to inform your doctor if you have any other medical problems, especially:

• Bone disease (e.g., osteosarcoma, Paget's disease of bone)—Use with caution. This condition may worsen.

• Kidney disease—Use with caution. The effects may be stronger due to slower elimination of the medicine from the body.

Along with its needed effects, a medicine can cause some unwanted effects. Not all of these side effects may happen, but if they do, you might need medical attention.

Check with your doctor right away if any of the following side effects occur:

More common

• Abdominal or stomach cramps or pain
• blurred vision
• confusion
• constipation
• convulsions
• depression
• difficulty with breathing
• dizziness
• dry mouth
• headache
• incoherent speech
• increased urination
• irregular heartbeats
• loss of appetite
• metallic taste
• muscle cramps in the hands, arms, feet, legs, or face
• muscle weakness
• nausea
• nervousness
• numbness and tingling around the mouth, fingertips, or feet
• pounding in the ears
• slow or fast heartbeat
• thirst
• tremor
• unusual tiredness
• vomiting
• weight loss

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your healthcare professional may also be able to provide ways to prevent or reduce some of these side effects. Check with your healthcare professional if any of the following side effects continue, are bothersome, or if you have questions about them:

More common

• Abnormal or decreased touch sensation
• body aches or pain
• chills
• cough
• diarrhea
• difficulty with moving
• ear congestion
• fever
• loss of voice
• muscle pain or stiffness
• pain in the joints or neck
• pain or tenderness around the eyes and cheekbones
• sneezing
• sore throat
• stuffy or runny nose
• tightness of the chest
• upper abdominal or stomach pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Natpara

Pharmacologic Class: Parathyroid

A doctor or other trained health professional will give you this medicine. This medicine is given as a shot under your skin, usually on the upper thighs.

You may be taught how to give this medicine at home. Make sure you understand all of the instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.

This medicine comes with a Medication Guide and patient instructions. Read and follow the instructions carefully. Ask your doctor if you have any questions about:

• How to prepare the injection using the medication cartridge and mixing device.
• The proper use of disposable syringes.
• How to give the injection using the reusable Q-Cliq pen injector.
• How long the injection can be stored at home.

If you have any questions about any of this, check with your doctor.

The medicine should be clear. Do not use the medicine if it is cloudy, discolored, or has large particles in it.

Follow your doctor's instructions about how to take vitamin D and calcium supplements while using this medicine.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form:For low calcium levels: Adults—Dose must be determined by your doctor. The starting dose is usually 50 microgram (mcg) injected under the skin once a day. Your doctor may adjust your dose every 4 weeks as needed. However, the dose is usually not more than 100 mcg per day. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

After mixing Natpara®, store the medication cartridge in the Q-Cliq pen in the refrigerator for up to 14 days. Store away from heat and light. Do not freeze or shake. Throw away any unused mixed medicine in the medication cartridges after 14 days.

Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.