CinnoPar (Teriparatide) for Osteoporosis

CinnoPar is a prescription drug that is like a natural hormone secreted by parathyroid glands called parathyroid hormone or PTH.

CinnoPar stimulates bone formation and increases bone mineral density and bone strength. It can also reduce the number of fractures of the spine and other bones in postmenopausal women with osteoporosis.

CinnoPar is used in both postmenopausal women and men with osteoporosis who are at high risk for having fractures.

CinnoPar can be used by people who have multiple risk factors for fracture, fracture related to osteoporosis, or who cannot use other osteoporosis treatments.

Also, CinnoPar is indicated for the treatment of women and men with osteoporosis associated with sustained systemic glucocorticoid therapy at high risk for fracture.

Do not use CinnoPar if you:

• Are a young adult or child whose bones are still growing.

• Are allergic to teriparatide or any of the components present in CinnoPar.

• Have Paget’s disease (have unexplained high blood levels of alkaline phosphatase).

• Have ever been diagnosed with bone cancer or other cancers that have spread to your bones.

• Have had radiation therapy involving the skeleton.

• Have or had too much calcium in your blood.

• Have or had bone diseases.

CinnoPar should only be used to treat osteoporotic patients who are considered to be at high risk for fracture and should not be used to prevent osteoporosis.

Tell your doctor about all of your medical conditions including if you:

• Have or had kidney diseases including kidney stones.

• Have trouble injecting yourself and do not have someone who can help you.

• Have hepatic impairment.

• Have cardiovascular diseases.

• Have hyperparathyroidism.

• Are pregnant or planning to become pregnant. It is not known if CinnoPar can harm your unborn baby.

• Are breastfeeding or planning to breastfeed. It is not known if CinnoPar can pass into breast milk.

Before taking CinnoPar, tell your doctor about all the medicines you take including prescriptions, non-prescription medicines, vitamins, and herbal supplements.

Especially tell your doctor if you take medicines that contain digoxin (for example, Lanoxicaps, Digoxin, Lanoxin) or digitalis.

• Use CinnoPar exactly as your doctor tells you and how it was prescribed for you.

• CinnoPar shouldn’t be used for more than two years.

• You can take CinnoPar with or without food or drink.

• You can take CinnoPar at any time of the day but at the same time.

Usual Adult Dose for Osteoporosis:

20 mcg (8 unit from pen) subcutaneously once a day into the thigh or abdominal wall.

Most side effects are mild and include:

• Vertigo and dizziness

• Nausea

• Leg cramps

• Orthostatic Hypotension. Some patients may have palpitations or feel lightheaded right after the first few doses. This usually begins within 4 hours of taking CinnoPar and resolves within a few hours. For the first few doses, take CinnoPar in a place where you can sit or lie down right away if you get these symptoms. If your symptoms get worse or do not go away, stop taking CinnoPar and call your doctor

• Joint aches

• Increased calcium in your blood. Tell your doctor if you have constipation, low energy, persistent nausea, vomiting, or muscle weakness. These may be the symptoms of hypercalcemia

• Injection site reactions including itching, a few drops of blood, redness, swelling, pain, and bruising

Your doctor may take samples of blood and urine during treatment to check your response to CinnoPar. Also, your doctor may ask you to have to follow-up tests of bone mineral density.

• Hypersensitivity actions: CinnoPar is contraindicated in patients who have hypersensitivity reactions to teriparatide or any component of the formulation.

• Orthostatic hypotension: CinnoPar may cause orthostatic hypotension. Transient orthostatic hypotension usually occurs within 4 hours of dosing and within the first several doses.

• Urolithiasis: Use caution in patients with active or recent urolithiasis because of the risk of exacerbation.

• Osteosarcoma: In animal studies, teriparatide has been associated with an increase in osteosarcoma; risk was dependent on both dose and duration. Avoid use in patients with an increased risk of osteosarcoma (including Paget disease, unexplained elevation of alkaline phosphatase, prior radiation, prior external beam or implant radiation therapy involving the skeleton, or in patients with open epiphyses). Do not use in patients with a history of skeletal metastases, bone metastases, hyperparathyroidism, or preexisting hypercalcemia. CinnoPar shouldn’t be used in patients with metabolic bone disease other than osteoporosis.

• Keep the CinnoPar pen in the refrigerator at 2 to 8 °C

• Do not freeze the CinnoPar pen

• Throw away the CinnoPar pen after 30 days

• Keep CinnoPar out of reach of children