2.1 Recommended Dosage

The recommended dosage is 20 mcg given subcutaneously once a day. Instruct patients to take supplemental calcium and vitamin D if daily dietary intake is inadequate.

2.2 Administration Instructions

• Administer teriparatide injection as a subcutaneous injection into the thigh or abdominal region. Teriparatide injection is not approved for intravenous or intramuscular use.
• Teriparatide injection should be administered initially under circumstances in which the patient can sit or lie down if symptoms of orthostatic hypotension occur [see Warnings and Precautions (5.4)].
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration (teriparatide injection is a clear and colorless liquid). Do not use if solid particles appear or if the solution is cloudy or colored.
• Patients and/or caregivers who administer teriparatide injection should receive appropriate training and instruction on the proper use of the teriparatide injection delivery device from a qualified health professional.

2.3 Recommended Treatment Duration

Use of teriparatide for more than 2 years during a patient's lifetime should only be considered if a patient remains at or has returned to having a high risk for fracture [see Warnings and Precautions (5.1)].

5.1 Osteosarcoma

An increase in the incidence of osteosarcoma (a malignant bone tumor) was observed in male and female rats treated with teriparatide. Osteosarcoma has been reported in patients treated with teriparatide in the post marketing setting; however, an increased risk of osteosarcoma has not been observed in observational studies in humans. There are limited data assessing the risk of osteosarcoma beyond 2 years of teriparatide use [see Dosage and Administration (2.3), Adverse Reactions (6.2), Nonclinical Toxicology (13.1)].

Avoid teriparatide injection use in patients with (these patients are at increased baseline risk of osteosarcoma):

• Open epiphyses (pediatric and young adult patients) (teriparatide injection is not approved in pediatric patients) [see Use in Specific Populations (8.4)].
• Metabolic bone diseases other than osteoporosis, including Paget's disease of the bone.
• Bone metastases or a history of skeletal malignancies.
• Prior external beam or implant radiation therapy involving the skeleton.
• Hereditary disorders predisposing to osteosarcoma.

5.2 Hypercalcemia and Cutaneous Calcification

Hypercalcemia

Teriparatide has not been studied in patients with pre-existing hypercalcemia. Teriparatide may cause hypercalcemia and may exacerbate hypercalcemia in patients with pre-existing hypercalcemia [see Adverse Reactions (6.1, 6.2)]. Avoid teriparatide injection in patients known to have an underlying hypercalcemic disorder, such as primary hyperparathyroidism.

Risk of Cutaneous Calcification Including Calciphylaxis

Serious reports of calciphylaxis and worsening of previously stable cutaneous calcification have been reported in the post-marketing setting in patients taking teriparatide. Risk factors for development of calciphylaxis include underlying autoimmune disease, kidney failure, and concomitant warfarin or systemic corticosteroid use. Discontinue teriparatide injection in patients who develop calciphylaxis or worsening of previously stable cutaneous calcification.

5.3 Risk of Urolithiasis

In clinical trials, the frequency of urolithiasis was similar in patients treated with teriparatide and patients treated with placebo. However, teriparatide has not been studied in patients with active urolithiasis. If teriparatide injection-treated patients have pre-existing hypercalciuria or suspected/known active urolithiasis, consider measuring urinary calcium excretion. Consider the risks and benefits of use in patients with active or recent urolithiasis because of the potential to exacerbate this condition.

5.4 Orthostatic Hypotension

Teriparatide injection should be administered initially under circumstances in which the patient can sit or lie down if symptoms of orthostatic hypotension occur. In short-term clinical pharmacology studies of teriparatide in healthy volunteers, transient episodes of symptomatic orthostatic hypotension were observed in 5% of volunteers. Typically, these events began within 4 hours of dosing and resolved (without treatment) within a few minutes to a few hours. When transient orthostatic hypotension occurred, it happened within the first several doses, it was relieved by placing the person in a reclining position, and it did not preclude continued treatment.

5.5 Risk of Digoxin Toxicity

Hypercalcemia may predispose patients to digitalis toxicity because teriparatide transiently increases serum calcium. Consider the potential onset of signs and symptoms of digitalis toxicity when teriparatide injection is used in patients receiving digoxin [see Drug Interactions (7.1), Clinical Pharmacology (12.3)].

6.1 Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

6.2 Postmarketing Experience

Adverse Reactions from Postmarketing Spontaneous Reports

The following adverse reactions have been identified during post-approval use of teriparatide. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

• Cases of bone tumor and osteosarcoma have been reported rarely in the postmarketing period [see Warnings and Precautions (5.1)].
• Hypercalcemia greater than 13 mg/dL has been reported with teriparatide use.

Adverse events reported since market introduction that were temporally related to teriparatide therapy include the following:

• Allergic Reactions: Anaphylactic reactions, drug hypersensitivity, angioedema, urticaria
• Investigations: Hyperuricemia
• Respiratory System: Acute dyspnea, chest pain
• Musculoskeletal: Muscle spasms of the leg or back
• Other: Injection site reactions including injection site pain, swelling and bruising; oro-facial edema

Adverse Reactions from Observational Studies to Assess Incidence of Osteosarcoma

Two osteosarcoma surveillance safety studies (U.S. claims-based database studies) were designed to obtain data on the incidence rate of osteosarcoma among teriparatide-treated patients. In these two studies, three and zero osteosarcoma cases were identified among 379,283 and 153,316 teriparatide users, respectively. The study results suggest a similar risk for osteosarcoma between teriparatide users and their comparators. However, the interpretation of the study results calls for caution owing to the limitations of the data sources which do not allow for complete measurement and control for confounders.

7.1 Digoxin

Sporadic case reports have suggested that hypercalcemia may predispose patients to digitalis toxicity. Teriparatide may transiently increase serum calcium. Consider the potential onset of signs and symptoms of digitalis toxicity when teriparatide injection is used in patients receiving digoxin [see Warnings and Precautions (5.5), Clinical Pharmacology (12.3)].

8.1 Pregnancy

Risk Summary

There are no available data on teriparatide injection use in pregnant women to evaluate for drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Consider discontinuing teriparatide injection when pregnancy is recognized.

In animal reproduction studies, teriparatide increased skeletal deviations and variations in mouse offspring at subcutaneous doses equivalent to more than 60 times the recommended 20 mcg human daily dose (based on body surface area, mcg/m2), and produced mild growth retardation and reduced motor activity in rat offspring at subcutaneous doses equivalent to more than 120 times the human dose (see Data).

The background risk of major birth defects and miscarriage for the indicated population is unknown. The background risk in the US general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies.

Data

Animal Data

In animal reproduction studies, pregnant mice received teriparatide during organogenesis at subcutaneous doses equivalent to 8 to 267 times the human dose (based on body surface area, mcg/m2). At subcutaneous doses ≥60 times the human dose, the fetuses showed an increased incidence of skeletal deviations or variations (interrupted rib, extra vertebra or rib). When pregnant rats received teriparatide during organogenesis at subcutaneous doses 16 to 540 times the human dose, the fetuses showed no abnormal findings.

In a perinatal/postnatal study in pregnant rats dosed subcutaneously from organogenesis through lactation, mild growth retardation was observed in female offspring at doses ≥120 times the human dose. Mild growth retardation in male offspring and reduced motor activity in both male and female offspring were observed at maternal doses of 540 times the human dose. There were no developmental or reproductive effects in mice or rats at doses 8 or 16 times the human dose, respectively.

8.2 Lactation

Risk Summary

It is not known whether teriparatide is excreted in human milk, affects human milk production, or has effects on the breast fed infant. Avoid teriparatide injection use in women who are breastfeeding.

8.4 Pediatric Use

The safety and effectiveness of teriparatide have not been established in pediatric patients. Pediatric patients are at higher baseline risk of osteosarcoma because of open epiphyses [see Warnings and Precautions (5.1)].

8.5 Geriatric Use

Of the patients who received teriparatide in the osteoporosis trial of 1637 postmenopausal women, 75% were 65 years of age and older and 23% were 75 years of age and older. Of the patients who received teriparatide in the trial of 437 men with primary or hypogonadal osteoporosis, 39% were 65 years of age and over and 13% were 75 years of age and over. Of the 214 patients who received teriparatide in the glucocorticoid induced osteoporosis trial, 28% were 65 years of age and older and 9% were 75 years of age and older. No overall differences in safety or effectiveness of teriparatide have been observed between patients 65 years of age and older and younger adult patients.

8.6 Hepatic Impairment

No studies have been performed in patients with hepatic impairment [see Clinical Pharmacology (12.3)].

8.7 Renal Impairment

In 5 patients with severe renal impairment (CrCl <30 mL/minute), the AUC and T1/2 of teriparatide were increased by 73% and 77%, respectively. Maximum serum concentration of teriparatide was not increased. It is unknown whether teriparatide alters the underlying metabolic bone disease seen in chronic renal impairment [see Clinical Pharmacology (12.3)].

12.1 Mechanism of Action

Endogenous 84-amino acid parathyroid hormone (PTH) is the primary regulator of calcium and phosphate metabolism in bone and kidney. Physiological actions of PTH include regulation of bone metabolism, renal tubular reabsorption of calcium and phosphate, and intestinal calcium absorption. The biological actions of PTH and teriparatide are mediated through binding to specific high-affinity cell-surface receptors. Teriparatide and the 34 N-terminal amino acids of PTH bind to these receptors with the same affinity and have the same physiological actions on bone and kidney. Teriparatide is not expected to accumulate in bone or other tissues.

The skeletal effects of teriparatide depend upon the pattern of systemic exposure. Once-daily administration of teriparatide stimulates new bone formation on trabecular and cortical (periosteal and/or endosteal) bone surfaces by preferential stimulation of osteoblastic activity over osteoclastic activity. In monkey studies, teriparatide improved trabecular microarchitecture and increased bone mass and strength by stimulating new bone formation in both cancellous and cortical bone. In humans, the anabolic effects of teriparatide manifest as an increase in skeletal mass, an increase in markers of bone formation and resorption, and an increase in bone strength. By contrast, continuous excess of endogenous PTH, as occurs in hyperparathyroidism, may be detrimental to the skeleton because bone resorption may be stimulated more than bone formation.

12.2 Pharmacodynamics

Pharmacodynamics in Men with Primary or Hypogonadal Osteoporosis and Postmenopausal Women with Osteoporosis

12.3 Pharmacokinetics

The pharmacokinetic parameters of teriparatide following single subcutaneous administration of teriparatide injection in patients with osteoporosis are shown in Table 2.

12.6 Immunogenicity

The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies in the studies described below with the incidence of anti-drug antibodies in other studies, including those of teriparatide or of other teriparatide products.

The immunogenicity profile of teriparatide injection was evaluated in a 24-week randomized trial comparing the effects of teriparatide injection 20 mcg daily with another teriparatide product 20 mcg daily. In this trial, 2.2% (2/90) subjects who received teriparatide injection and 2.2% (2/91) subjects who received the other teriparatide product had detectable antibodies to teriparatide and one out of the two teriparatide injection treated patients developed neutralizing antibodies to teriparatide.

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

Two carcinogenicity bioassays were conducted in Fischer 344 rats. In the first study, male and female rats were given daily subcutaneous teriparatide injections of 5, 30, or 75 mcg/kg/day for 24 months from 2 months of age. These doses resulted in rat systemic exposures that were 3, 20, and 60 times higher than the systemic exposure observed in humans, respectively, following a subcutaneous dose of 20 mcg (based on AUC comparison). Teriparatide treatment resulted in a marked dose-related increase in the incidence of osteosarcoma, a rare malignant bone tumor, in both male and female rats. Osteosarcomas were observed at all doses and the incidence reached 40% to 50% in the high-dose groups. Teriparatide also caused a dose-related increase in osteoblastoma and osteoma in both sexes. No osteosarcomas, osteoblastomas or osteomas were observed in untreated control rats. The bone tumors in rats occurred in association with a large increase in bone mass and focal osteoblast hyperplasia.

The second 2-year study was carried out in order to determine the effect of treatment duration and animal age on the development of bone tumors. Female rats were treated for different periods between 2 and 26 months of age with subcutaneous doses of 5 and 30 mcg/kg (equivalent to 3 and 20 times the human exposure at the 20-mcg dose, respectively, based on AUC comparison). The study showed that the occurrence of osteosarcoma, osteoblastoma and osteoma was dependent upon dose and duration of exposure. Bone tumors were observed when immature 2-month old rats were treated with 30 mcg/kg/day of teriparatide for 24 months or with 5 or 30 mcg/kg/day of teriparatide for 6 months. Bone tumors were also observed when mature 6-month old rats were treated with 30 mcg/kg/day of teriparatide for 6 or 20 months. Tumors were not detected when mature 6-month old rats were treated with 5 mcg/kg/day of teriparatide for 6 or 20 months. The results did not demonstrate a difference in susceptibility to bone tumor formation, associated with teriparatide treatment, between mature and immature rats.

No bone tumors were detected in a long-term monkey study [see Nonclinical Toxicology (13.2)].

Mutagenesis

Teriparatide was not genotoxic in any of the following test systems: the Ames test for bacterial mutagenesis; the mouse lymphoma assay for mammalian cell mutation; the chromosomal aberration assay in Chinese hamster ovary cells, with and without metabolic activation; and the in vivo micronucleus test in mice.

Impairment of Fertility

No effects on fertility were observed in male and female rats given subcutaneous teriparatide doses of 30, 100, or 300 mcg/kg/day prior to mating and in females continuing through gestation Day 6 (16 to 160 times the human dose of 20 mcg based on surface area, mcg/m2).

13.2 Animal Toxicology and/or Pharmacology

In single-dose rodent studies using subcutaneous injection of teriparatide, no mortality was seen in rats given doses of 1000 mcg/kg (540 times the human dose based on surface area, mcg/m2) or in mice given 10,000 mcg/kg (2700 times the human dose based on surface area, mcg/m2).

In a long-term study, skeletally mature ovariectomized female monkeys (N=30 per treatment group) were given either daily subcutaneous teriparatide injections of 5 mcg/kg or vehicle. Following the 18-month treatment period, the monkeys were removed from teriparatide treatment and were observed for an additional 3 years. The 5 mcg/kg dose resulted in systemic exposures that were approximately 6 times higher than the systemic exposure observed in humans following a subcutaneous dose of 20 mcg (based on AUC comparison). Bone tumors were not detected by radiographic or histologic evaluation in any monkey in the study.

14.1 Treatment of Osteoporosis in Postmenopausal Women

The safety and efficacy of once-daily teriparatide, median exposure of 19 months, were examined in a double-blind, multicenter, placebo-controlled clinical study of 1637 postmenopausal women with osteoporosis. In this study 541 postmenopausal women were treated with 20 mcg teriparatide subcutaneously once daily.

All women received 1000 mg of calcium and at least 400 IU of vitamin D per day. Baseline and endpoint spinal radiographs were evaluated using the semiquantitative scoring. Ninety percent of the women in the study had 1 or more radiographically diagnosed vertebral fractures at baseline. The primary efficacy endpoint was the occurrence of new radiographically diagnosed vertebral fractures defined as changes in the height of previously undeformed vertebrae. Such fractures are not necessarily symptomatic.

New Nonvertebral Osteoporotic Fractures — Teriparatide significantly reduced the risk of any nonvertebral fracture from 5.5% in the placebo group to 2.6% in the teriparatide group (p <0.05). The absolute reduction in risk was 2.9% and the relative reduction was 53%. The incidence of new nonvertebral fractures in the teriparatide group compared with the placebo group was ankle/foot (0.2%, 0.7%), hip (0.2%, 0.7%), humerus (0.4%, 0.4%), pelvis (0%, 0.6%), ribs (0.6%, 0.9%), wrist (0.4%, 1.3%), and other sites (1.1%, 1.5%), respectively.

The cumulative percentage of postmenopausal women with osteoporosis who sustained new nonvertebral fractures was lower in women treated with teriparatide than in women treated with placebo (see Figure 1).

Figure 1: Cumulative Percentage of Postmenopausal Women with Osteoporosis Sustaining New Nonvertebral Osteoporotic Fractures

14.2 Treatment to Increase Bone Mass in Men with Primary or Hypogonadal Osteoporosis

The safety and efficacy of once-daily teriparatide, median exposure of 10 months, were examined in a double-blind, multicenter, placebo-controlled clinical study of 437 men with either primary (idiopathic) or hypogonadal osteoporosis. In this study, 151 men received 20 mcg of teriparatide given subcutaneously once daily. All men received 1000 mg of calcium and at least 400 IU of vitamin D per day. The primary efficacy endpoint was change in lumbar spine BMD.

Teriparatide increased lumbar spine BMD in men with primary or hypogonadal osteoporosis. Statistically significant increases were seen at 3 months and continued throughout the treatment period. Teriparatide was effective in increasing lumbar spine BMD regardless of age, baseline rate of bone turnover, and baseline BMD. The effects of teriparatide at additional skeletal sites are shown in Table 5.

Teriparatide treatment for a median of 10 months increased lumbar spine BMD from baseline in 94% of men treated. Fifty-three percent of patients treated with teriparatide achieved at least a 5% increase in spine BMD, and 14% gained 10% or more.

14.3 Treatment of Men and Women with Glucocorticoid-Induced Osteoporosis

The efficacy of teriparatide for treating glucocorticoid-induced osteoporosis was assessed in a randomized, double-blind, active-controlled trial of 428 patients (19% men, 81% women) aged 22 to 89 years (mean 57 years) treated with ≥5 mg/day prednisone or equivalent for a minimum of 3 months. The duration of the trial was 18 months. In the trial 214 patients were treated with teriparatide 20 mcg given subcutaneously once daily. In the teriparatide group, the baseline median glucocorticoid dose was 7.5 mg/day and the baseline median duration of glucocorticoid use was 1.5 years. The mean (SD) baseline lumbar spine BMD was 0.85 ± 0.13 g/cm2 and lumbar spine BMD T-score was –2.5 ± 1 (number of standard deviations below the mean BMD value for healthy adults). A total of 30% of patients had prevalent vertebral fracture(s) and 43% had prior non-vertebral fracture(s). The patients had chronic rheumatologic, respiratory or other diseases that required sustained glucocorticoid therapy. All patients received 1000 mg of calcium plus 800 IU of vitamin D supplementation per day.

Because of differences in mechanism of action (anabolic vs. anti-resorptive) and lack of clarity regarding differences in BMD as an adequate predictor of fracture efficacy, data on the active comparator are not presented.

Effect on Bone Mineral Density (BMD)

In patients with glucocorticoid-induced osteoporosis, teriparatide increased lumbar spine BMD compared with baseline at 3 months through 18 months of treatment. In patients treated with teriparatide, the mean percent change in BMD from baseline to endpoint was 7.2% at the lumbar spine, 3.6% at the total hip, and 3.7% at the femoral neck (p<0.001 all sites). The relative treatment effects of teriparatide were consistent in subgroups defined by gender, age, geographic region, body mass index, underlying disease, prevalent vertebral fracture, baseline glucocorticoid dose, prior bisphosphonate use, and glucocorticoid discontinuation during trial.

16.1 How Supplied

Teriparatide injection is a colorless solution, available as single-patient-use pens in the following package size:

• 620 mcg/2.48 mL (250 mcg/mL) NDC 47781-652-89.

16.2 Storage and Handling

• The teriparatide injection delivery device should be stored under refrigeration at 2°C to 8°C (36°F to 46°F) at all times.
• Recap the delivery device when not in use to protect the cartridge from physical damage and light.
• When using teriparatide injection, minimize the time out of the refrigerator; deliver the dose immediately following removal from the refrigerator.
• Do not freeze. Do not use teriparatide injection if it has been frozen.

Prepare for Injection

1. Prepare Site and Remove the White Cap A) Wash hands prior to use. B) Prepare the injection site (thigh or abdomen) as recommended by your healthcare provider. C) Remove the white cap by pulling it straight off of the device (Figure B).

2. Check Device, Device Label and Medication A) Check the device. DO NOT use the teriparatide injection device if it is damaged. B) Check the label on the device. DO NOT use if the device contains the incorrect medication or if the medication has expired (Figure C). C) Check the medication cartridge. The liquid medication should be clear and colorless. DO NOT use the medication if it is cloudy, colored, or has floating particles. (Figure C).

3. Attach New Needle A) Peel off the paper tab (Figure D). B) Push the needle straight onto medicine cartridge. Screw on needle clockwise until firmly attached (Figure E and Figure F). DO NOT over-tighten the needle.

4. Remove Outer Needle Cover Pull off large outer needle cover (Figure G), and save it for later (see Step 9).

5. Set Dose Pull out the black injection button until it stops (Figure H). Check to make sure red stripe shows. Additionally, the instruction window will show an arrow pointing towards the needle end of the device (Figure I).

Troubleshooting If the device does not set fully or if you cannot pull back on the black injection button refer to Troubleshooting Problem E on the back page.

Administer Injection

6. Remove Inner Needle Cover A) Pull off small inner needle protector and throw it away (Figure J). B) CAUTION: The needle will be exposed.

7. Inject Dose A) Gently hold a fold of skin on your thigh or abdomen and insert the needle straight into the folded skin (Figure K). B) Press the black injection button down until it stops and hold (Figure L). C) Hold it in and count to 5 slowly. You must wait until the count of 5 to make sure the full dose has been delivered (Figure M). D) Remove the needle from the skin (Figure N). Once needle is removed from skin, take your thumb off the black injection button.

Note: You may not see the plunger moving. To confirm that your dose has been delivered, see Step 8.

After Injection

8. Confirm Dose Check to make sure the black injection button is all the way down. The instruction window will show an arrow pointing towards the black button. If the yellow shaft does not show, you have finished the injection steps the right way (Figure O).

Important You should not see any of the yellow shaft. If you do and have already injected the medicine, do not inject yourself a second time in the same day. Instead, you must reset the device. Refer to Troubleshooting Problem A on the back page for more information.

9. Remove Needle and Dispose A) Put the large outer needle cover on the needle by scooping it up and pressing it on (Figure P and Figure Q). Do not try to put the needle cover back on with your hands. B) Unscrew the covered needle all the way by giving the large needle cover 3-5 counter-clockwise turns (Figure R). Pull the needle straight off (Figure S). C) Dispose of the needle into a puncture resistant container according to local regulations (Figure T). DO NOT reuse needle.

Disposal Information For more information about how to correctly dispose of the needle refer to the Disposal Information section on the back page.

10. Recap Device and Store A) Push white cap back on (Figure U). B) Always store the device in the refrigerator with the white cap on right after use (Figure V). DO NOT store the device with a needle attached.

Revised: November 2019

See Reverse Side for More Information

Troubleshooting

Problem	Solution
A. The yellow shaft is still showing after I push in the black injection button. How do I reset my teriparatide injection delivery device?	To reset the teriparatide injection delivery device, follow the steps below: 1) If you have already injected, DO NOT inject yourself a second time on the same day. 2) Remove the needle and dispose in a sharps container according to local regulations. 3) Attach a new needle, pull off the large needle cover and save it. 4) Pull off the inner needle cover and throw away. 5) Point the needle down into an empty container. Push in the black injection button until it stops. Hold it in and slowly count to five. You may see a small stream or a drop of fluid. When you have finished, the black injection button should be all the way in. 6) If you still see the yellow shaft showing, contact Alvogen, Inc. (see Contact Information below and to the right) or your healthcare provider. 7) Remove the needle and dispose in a sharps container according to local regulations. Push the white cap back on, and put your teriparatide injection delivery device in the refrigerator. You can prevent this problem by always using a NEW needle for each injection, and by pushing the black injection button all the way in and slowly counting to five.
B. How can I tell if my teriparatide injection delivery device works?	The black injection button should be all the way in to show that the full dose of medicine has been injected from the teriparatide injection delivery device. Use a new needle every time you inject to be sure your teriparatide injection delivery device will work properly.
C. I see an air bubble in my teriparatide injection delivery device.	A small air bubble will not affect your dose and it will not harm you. You can continue to take your dose as usual.
D. I cannot get the needle off.	1) Put the large needle cover on the needle. 2) Use the large needle cover to unscrew the needle. 3) Unscrew the needle all the way by giving the large needle cover 3 to 5 counter-clockwise turns. 4) If you still cannot get the needle off, ask someone to help you.
E. What should I do if I have difficulty pulling out the black injection button?	Change to a new teriparatide injection delivery device to take your dose as instructed by your healthcare provider. When the black injection button becomes hard to pull out, this means there is not enough medicine in your teriparatide injection delivery device for another dose. You may still see some medicine left in the cartridge.

Disposal Information

Put your used needles in a FDA-cleared sharps disposal container right away after use.

DO NOT throw away (dispose of) loose needles in your household trash.

If you do not have a FDA-cleared sharps disposal container, you may use a container that is:

• Made of a heavy-duty plastic
• Can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out
• Upright and stable during use
• Leak-resistant
• Properly labeled to warn of hazardous waste inside the container

When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles.

For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.

DO NOT dispose of your used sharps disposal container in your household trash unless your community guidelines permit this.

DO NOT recycle your used sharps disposal container.

Cleaning and Storage

Cleaning Your Teriparatide Injection Delivery Device

• Wipe the outside of the teriparatide injection delivery device with a damp cloth.
• Do not place the teriparatide injection delivery device in water, or wash or clean it with any liquid.

Storing Your Teriparatide Injection Delivery Device

• After each use, refrigerate the teriparatide injection delivery device right away. Read and follow the instructions in the Medication Guide section "How should I store teriparatide injection?".
• DO NOT store the teriparatide injection delivery device with a needle attached. Doing this may cause air bubbles to form in the medicine cartridge.
• Store the teriparatide injection delivery device with the white cap on.
• DO NOT freeze teriparatide injection. If the teriparatide injection delivery device has been frozen, throw the device away and use a new teriparatide injection delivery device. If the teriparatide injection delivery device has been left out of the refrigerator, do not throw the delivery device away. Place the delivery device back in the refrigerator and call Alvogen, Inc. (see Contact Information below).

Other Important Notes

• The teriparatide injection delivery device contains 28 days of medicine.
• DO NOT transfer teriparatide injection to a syringe. This may result in you taking the wrong dose of medicine.
• Read and follow the instructions in the User Manual so that you use your teriparatide injection delivery device the right way.
• Check the teriparatide injection delivery device label to make sure you have the right medicine and that it has not expired.
• DO NOT use the teriparatide injection delivery device if it looks damaged. Look at the teriparatide injection medicine in the cartridge. If the medicine is not clear and colorless, or if it has particles, do not use it. Call Alvogen, Inc. if you notice any of these (see Contact Information below).
• Use a new needle for each injection.
• During injection, you may hear one or more clicks - this is normal.
• The teriparatide injection delivery device is not recommended for use by the blind or by those who have vision problems without help from a person trained in the proper use of the device.
• Keep your teriparatide injection delivery device and needles out of the reach of children.

Disposal of Pen Needles and Delivery Device

Disposal of Pen Needles and the Teriparatide Injection Delivery Device

• Before throwing away the teriparatide injection delivery device, be sure to remove the pen needle.
• Throw away your teriparatide injection delivery device and used needles as instructed by your healthcare provider, local or state laws, or institutional policies.

Contact Information

If you have questions, need help or for more information with your teriparatide injection delivery device, contact Alvogen, Inc. at 1-866-770-3024 or your healthcare provider.

Distributed by: Alvogen, Inc.
Morristown, NJ 07960 USA

Revised: November 2019
IFU652-04