Tymlos

Last updated on RxList: 10/30/2020
Tymlos Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Tymlos?

Tymlos (abaloparatide) injection is a human parathyroid hormone related peptide [PTHrP(1-34)] analog indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture.

What Are Side Effects of Tymlos?

Common side effects of Tymlos include:

Dosage for Tymlos

The recommended dose of Tymlos is 80 mcg subcutaneously once daily; patients should receive supplemental calcium and vitamin D if dietary intake is inadequate.

What Drugs, Substances, or Supplements Interact with Tymlos?

Tymlos may interact with other drugs. Tell your doctor all medications and supplements you use.

Tymlos During Pregnancy and Breastfeeding

Tymlos is not indicated for use in females of reproductive potential; consult your doctor if you are pregnant or breastfeeding.

Additional Information

Our Tymlos (abaloparatide) Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

What is another medical term for osteoporosis? See Answer
Tymlos Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • a light-headed feeling, like you might pass out (may occur within 4 hours after injection);
  • bone pain;
  • unusual body aches;
  • a new or worsening lump or swelling under your skin;
  • pounding heartbeats or fluttering in your chest;
  • high calcium levels--confusion, tiredness, nausea, vomiting, loss of appetite, constipation, increased thirst or urination, weight loss; or
  • symptoms of a kidney stone--severe pain in your side or lower back, blood in your urine, painful urination.

Common side effects may include:

  • dizziness, spinning sensation;
  • headache;
  • fast heart rate;
  • nausea, upper stomach pain; or
  • feeling very tired.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Tymlos (Abaloparatide Injection)

SLIDESHOW

Osteoporosis Super-Foods for Strong Bones With Pictures See Slideshow
Tymlos Professional Information

SIDE EFFECTS

The following adverse reactions are described in greater detail in other sections:

  • Orthostatic Hypotension [see WARNINGS AND PRECAUTIONS]
  • Hypercalcemia [see WARNINGS AND PRECAUTIONS]
  • Hypercalciuria and Urolithiasis [see WARNINGS AND PRECAUTIONS]

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.

Postmenopausal Women With Osteoporosis

The safety of TYMLOS was evaluated in a randomized, multicenter, double-blind, placebocontrolled clinical trial in postmenopausal women with osteoporosis aged 49 to 86 years (mean age 69 years) who were randomized to receive 80 mcg of TYMLOS (N = 824) or placebo (N = 821), given subcutaneously once daily for 18 months [see Clinical Studies].

In this study, the incidence of all-cause mortality was 0.4% in the TYMLOS group and 0.6% in the placebo group. The incidence of serious adverse events was 10% in the TYMLOS group and 11% in the placebo group. The percentage of patients who discontinued study drug due to adverse events was 10% in the TYMLOS group and 6% in the placebo group. The most common adverse reactions leading to study drug discontinuation in the TYMLOS group were nausea (2%), dizziness (1%), headache (1%), and palpitations (1%).

Table 1 shows the most common adverse reactions in the trial. These adverse reactions were generally not present at baseline, occurred more commonly with TYMLOS than with placebo, and occurred in at least 2% of the patients treated with TYMLOS.

Table 1: Common Adverse Reactions Reported in Postmenopausal Women with Osteoporosis*

Preferred termTYMLOS
(N=822) (%)
Placebo
(N=820) (%)
Hypercalciuria119
Dizziness106
Nausea83
Headache86
Palpitations50.4
Fatigue32
Abdominal pain upper32
Vertigo22
* Adverse reactions reported in ≥2% of TYMLOS-treated patients.

Orthostatic Hypotension

In the clinical trial of women with postmenopausal osteoporosis, the incidence of orthostatic blood pressure decline ≥20 mmHg systolic or ≥10 mmHg diastolic at 1 hour after the first injection was 4% in the TYMLOS group and 3% in the placebo group. At later time points the incidence was generally similar between the treatment groups. Adverse reactions of orthostatic hypotension were reported in 1% of patients receiving TYMLOS and 0.5% of patients receiving placebo. Dizziness was reported by more TYMLOS-treated patients (10%) compared to placebo (6%) [see WARNINGS AND PRECAUTIONS].

Tachycardia

In women with postmenopausal osteoporosis, adverse reactions of tachycardia, including sinus tachycardia, were reported in 2% of patients receiving TYMLOS and 1% of patients in the placebo group. In 5 of the 13 patients receiving TYMLOS who experienced tachycardia, symptoms occurred within 1 hour of administration. TYMLOS has been associated with a dosedependent increase in heart rate which developed within 15 minutes after injection and resolved in about 6 hours [see CLINICAL PHARMACOLOGY].

Injection Site Reactions

During the first month of the trial, injection site reactions were assessed daily one-hour after injection. TYMLOS had a higher incidence than placebo of injection site redness (58% vs. 28%), edema (10% vs. 3%) and pain (9% vs. 7%). Severe redness, severe edema, and severe pain were reported among 2.9%, 0.4%, and 0.4% of the TYMLOS-treated patients.

Laboratory Abnormalities

Hypercalcemia

In the clinical trial of women with postmenopausal osteoporosis, TYMLOS caused increases in serum calcium concentrations [see WARNINGS AND PRECAUTIONS]. The incidence of hypercalcemia, defined as albumin-corrected serum calcium ≥10.7 mg/dL at 4 hours following injection at any visit was 3% in TYMLOS-treated patients and 0.1% with placebo. Pre-dose serum calcium was similar to baseline in both groups. There were 2 (0.2%) TYMLOS-treated patients and no placebo-treated patients who discontinued from the study due to hypercalcemia. The incidence of hypercalcemia with TYMLOS was higher in patients with mild or moderate renal impairment (4%) compared to patients with normal renal function (1%).

Increases In Serum Uric Acid

TYMLOS increased serum uric acid concentrations. In the postmenopausal osteoporosis trial, among patients with normal baseline uric acid concentrations, 25% of patients in the TYMLOS group and 6% of patients in the placebo group had at least one post-baseline concentration above the normal range. The hyperuricemia observed in TYMLOS-treated patients was not associated with an increase in adverse reactions of gout or arthralgia over that observed with placebo.

Hypercalciuria And Urolithiasis

In the clinical trial of women with postmenopausal osteoporosis, the overall incidence of urine calcium :creatinine ratio >400 mg/g was higher with TYMLOS than with placebo (20% vs 15%, respectively). Urolithiases were reported in 2.1% of TYMLOS-treated patients and 1.7% of placebo-treated patients.

Adverse Reactions From The Extension Study In Postmenopausal Women With Osteoporosis

Following 18 months of treatment with TYMLOS or placebo, 1139 women transitioned to treatment with alendronate 70 mg administered orally once weekly. The incidence of adverse events occurring during alendronate treatment was similar in patients with prior placebo or TYMLOS therapy [see Clinical Studies].

Immunogenicity

As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to TYMLOS in the studies described below with the incidence of antibodies in other studies or to other products may be misleading.

Of the patients receiving TYMLOS for 18 months, 49% (300/610) developed anti-abaloparatide antibodies, of these, 68% (201/297) developed neutralizing antibodies to abaloparatide. Of the patients with anti-abaloparatide antibodies tested for cross-reactivity, 2.3% (7/298) developed cross-reactivity to PTHrP, 43% (3/7) developed neutralizing antibodies to PTHrP, and 0% (0/298) developed cross-reactive antibodies to PTH. Antibody formation did not appear to have any clinically significant impact on safety or efficacy endpoints, including bone mineral density (BMD) response, fracture reduction, immune-related hypersensitivity or allergic reactions, or other adverse events.

Most of the patients with anti-abaloparatide antibodies during treatment with TYMLOS, 85% (256/300), had follow-up antibody measurements six months after completion of TYMLOS therapy. Among these patients, 56% (143/256) remained antibody positive.

Postmarketing Experience

The following adverse reactions have been identified during the post-approval use of TYMLOS. 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.

  • Abdominal distension, abdominal pain
  • Constipation, diarrhea, vomiting
  • Asthenia, lethargy, malaise
  • Insomnia
  • Hypersensitivity and anaphylactic reactions, dyspnea (in the context of allergic reactions)
  • Pruritus, rash
  • Generalized pain and pain in bone, joint, back, and extremity
  • Muscle spasms of the leg and back
  • Injection site reactions including bruising, hemorrhage, pruritus, and rash

Read the entire FDA prescribing information for Tymlos (Abaloparatide Injection)

© Tymlos Patient Information is supplied by Cerner Multum, Inc. and Tymlos Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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