Tymlos side effects

 

Generic name: abaloparatide
Brand name: Tymlos
Drug class: Parathyroid hormone and analogs

What is Tymlos?

tymlos side effects
Tymlos

Tymlos side effects are the unwanted reactions that can be observed while taking this medication

Tymlos is used in the treatment of osteoporosis in postmenopausal females who are at an increased chance of fractures of the bone.

Tymlos can also be employed for reasons not mentioned in this medication guide.

 

Tymlos side effects

The side effects that occur require immediate medical treatment

Tymlos its necessary effects In addition to its necessary effects, along with its necessary effects, abaloparatide (the active ingredient within Tymlos) can cause unwanted side effects. While none of these adverse effects can be present, if they do occur, they might require medical treatment.

Consult your physician immediately in the event that any of these adverse effects happen while you are taking Tymlos

More commonly

Less well-known

The exact cause is not known.

There are no immediate side effects that require medical care

Abaloparatide can cause side effects. can occur, but they usually don’t require medical care. These effects could be eliminated in the course of treatment as the body adapts to the medication. Additionally, your health care specialist may provide suggestions on ways to minimize or prevent the effects of these negative side consequences.

Talk to your doctor If any of the following adverse effects persist or become bothersome or should you have any concerns regarding these side effects:

More popular

Less well-known

Incidence unknown

Clinical Trials Experience

Since clinical studies are conducted in diverse conditions, the rate of adverse reactions that are observed in clinical studies of medication cannot be directly compared with rates that are observed in the clinical trials of a different drug. They might not be representative of the rate seen in actual use.

Postmenopausal women who suffer from Osteoporosis

The efficacy of TYMLOS was tested in a multicenter, randomized double-blind, placebo-controlled study of postmenopausal women suffering from osteoporosis between 49 and the age of 86 (mean of 69-69) who were randomly assigned to receive either 80 mg of TYMLOS (N 824) or placebo (N 821) Subcutaneously, once every day during 18 months. 

The rate for all-cause mortality was 0.4 % for the TYMLOS group and 0.6 % for the group with a placebo. The rate of serious adverse events was 10% for the TYMLOS group, and 11% in the placebo group. The proportion of patients who had to stop taking study drugs because of adverse reactions was 10 10% within the TYMLOS group, and 6 % within the control group.

The most frequent adverse reactions leading to discontinuation of study drugs within the TYMLOS group included nausea (2 %) dizziness (1 %) headache (1 %) and palpitations (1 %).

The following table lists the most frequent adverse reactions that occurred during the trial. These adverse reactions, which were usually not evident at the beginning of the trial but were more prevalent when patients were treated with TYMLOS as compared to placebo and were observed in at most 2 % of patients who were treated with TYMLOS.

 Common Adverse Reactions Identified by Postmenopausal Women who have Osteoporosis

Preferred term

TYMLOS
(N=822)
(%)
Placebo
(N=820)
(%)
     Hypercalciuria 11 9
     Dizziness 10 6
     Nausea 8 3
     Headache 8 6
     Palpitations 5 0.4
     Fatigue 3 2
     Abdominal pain upper 3 2
     Vertigo 2 2

Adverse reactions reported in ≥2% of TYMLOS-treated patients.

Orthostatic Hypotension

In the clinical study of women with osteoporosis postmenopausal the rate of a decline in orthostatic blood pressure greater than 20 mmHg systolic, or 10 diastolic pressure at 1 hour after the initial injection was 4% for the TYMLOS group, and 3percent of the group who received placebo. Later on, the prevalence was generally comparable to the treatment groups.

Orthostatic hypotension-related adverse reactions were reported by one % of patients who received TYMLOS and 0.5 % of patients taking placebo. Dizziness was reported more frequently by those treated with TYMLOS (10 %) as compared to placebo (6 %).

Tachycardia

For women suffering from postmenopausal osteoporosis, adverse reactions involving Tachycardia, such as sinus tachycardia, were observed in the 2% of patients taking TYMLOS and 1 % from patients who were in the placebo. In five of the 13 patients who received TYMLOS who had tachycardia symptoms the symptoms manifested within one hour of the administration. TYMLOS has been linked to an increased heartbeat that began within 15 minutes of injection and resolved in approximately six hours. 

Injection Site Reactions

At the beginning of the study, The reactions at the injection site were evaluated daily for one hour after the injection. TYMLOS was more likely than placebo for redness at the injection site (58 % against. 28 %) as well as swelling (10 % instead of. 3%)) as well as pain (9 % in comparison to. 7 %). Extreme redness, as well as severe edema as well as extreme pain, were observed in 2.9 %, 0.4%, and 0.4 % of TYMLOS patients.

Laboratory Abnormalities

Hypercalcemia

The clinical trial for patients with osteoporosis postmenopausal TYMLOS resulted in an increase in the levels of calcium in the serum. The prevalence of hypercalcemia which is defined as serum calcium corrected with albumin >=10.7 mg/dL after 4 hours following the injection at any time was 3.3% in TYMLOS treated % and 0.1 % in placebo.

The serum calcium levels prior to injection were similar to the baseline levels for both groups. There were two (0.2 %) patients treated with TYMLOS and none placebo-treated patients who were unable to continue the study because of hypercalcemia. The rate of hypercalcemia in patients treated due to TYMLOS was greater in patients suffering from moderate or mild renal impairment (4 %) in comparison to patients who had healthy renal function (1 %).

Increases in Serum Uric Acid

TYMLOS elevated serum uric acids concentrations. As part of the osteoporosis postmenopausal study in patients who had normal baseline uric acids levels 25 % of those within the TYMLOS group and 6% of those from the group with placebo had at the least one post-baseline level over what is normal.

The elevated uricemia seen in TYMLOS treated patients was not related to a rise in adverse reactions like arthritis or gout over those seen in the placebo group.

Hypercalciuria and Urolithiasis

In the clinical study of women suffering from postmenopausal osteoporosis the prevalence of urine calcium/creatinine ratios >400 mg/g was greater in patients treated with TYMLOS than in placebo (20 % vs. 15 % in both cases). Urolithiases were observed in 2.1 % of patients receiving TYMLOS and 1.7 % of placebo-treated patients.

Negative Reactions to The Extension Study in Postmenopausal Women who suffer from Osteoporosis

After an 18-month period of therapy by TYMLOS (or placebo), 1139 women were shifted for treatment using alendronate 70 mg, which was administered orally every week. The risk of adverse events that occurred during treatment with alendronate was similar to patients who had previously received placebo or TYMLOS treatment.

 

Immunogenicity

Like any therapeutic protein, it is possible to develop immunogenicity. The ability to detect the formation of antibodies is strongly dependent on the specificity and sensitivity of the test. Furthermore, the rate of antibodies (including neutralizing antibodies) positive results in an assay can be affected by various variables, including the method of assay and sample handling, the time of collection, the presence of concomitant medications and the root cause of the disease.

Therefore, comparing of the frequency of antibodies against TYMLOS within the research studies discussed below with the prevalence of antibodies from different studies or for other products could be incorrect.

Of patients treated with TYMLOS during the 18-month period, 49 % (300/610) created anti-abaloparatide antibodies Of these, 68 % (201/297) created neutralizing antibodies against abaloparatide. In the case of patients with anti-abaloparatide antibodies that were tested for cross-reactivity 2.3%(7/298) were cross-reactive to PTHrP. 43 % (3/7) produced neutralizing antibodies to PTHrP and the remaining 0% (0/298) produced cross-reactive antibodies to PTH.

The formation of antibodies did not appear to have any clinically significant effect on safety or efficacy outcomes for Bone mineral density (BMD) response and reduction in fractures, or adverse reactions.

The majority of patients who had anti-abaloparatide antibodies in the course of treatment with TYMLOS 85 % (256/300) were able to have follow-up test results six months after the completion of TYMLOS treatment. Of those patients 56 % (143/256) were antibody-positive.

Postmarketing Experience

These adverse effects have been observed in the post-approval usage of TYMLOS. Since these reactions are reported on a voluntary basis from an unknown population It isn’t always feasible to accurately estimate its frequency or to establish a causal connection to exposure to drugs.

  • Abdominal tension, abdominal pain
  • Constipation, diarrhea, vomiting
  • Asthenia, lethargy, malaise
  • Insomnia
  • Anaphylactic and hypersensitive reactions as well as dyspnea (in the case of reactions to allergens)
  • Rash, pruritus
  • Generalized pain and discomfort in the back, joint, bone and in the extremity
  • The leg muscles are tense and the back

Additional details

Always consult your physician to confirm that the information provided on this site is appropriate to your particular situation.

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