Xermelo (telotristat ethyl) for Cancer: Dosage & Interactions


What is Survanta, and how does it work?

Xermelo is indicated for the treatment of carcinoid syndrome diarrhea, which is diarrhea caused by cancerous tumors, in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy.

What are the side effects of Survanta?

Clinical Trials Experience

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

  • Xermelo was studied in a double-blind, placebo-controlled
    clinical trial of 90 patients with metastatic
    neuroendocrine tumors and
    carcinoid syndrome
    diarrhea.
  • Patients reported between 4 to 12 bowel movements daily despite the use
    of SSA therapy at a stable dose for at least 3 months. Placebo or Xermelo 250 mg was administered three times daily
    for 12 weeks.
  • Concomitant anti-diarrheal medications (e.g., loperamide) were
    used by 43% (36% and 51% in the placebo and Xermelo group, respectively),
    pancreatic
    enzyme replacement medications by 39% (36% and 42% in the placebo
    and Xermelo group, respectively), and
    opioid analgesics by 29% (24% and 33% in
    the placebo and Xermelo group, respectively) of patients during the 12-week
    double-blind period of the trial.

Table 1 below lists adverse reactions occurring at an
incidence of at least 5% in the Xermelo group (N=45) and at an incidence greater
than placebo (N=45) during the 12-week placebocontrolled period of the trial.

Table 1: Percent Common Adverse Reactionsa by
Treatment Group at 12-Weeks in a Double-Blind Placebo-Controlled Clinical Trial
of Patients with Carcinoid Syndrome Diarrhea

Adverse Reaction Xermelo 250 mg Three Times Daily,
N=45 (%)
Placebo,
N=45 (%)
Nausea 13 11
Headache 11 4
Increased gamma-glutamyl-transferase (GGT) 9 0
Depressionb 9 7
Peripheral edema 7 2
Flatulence 7 2
Decreased appetite 7 4
Pyrexia 7 4
a incidence of at least 5% in the Xermelo
group and at an incidence greater than placebo
b including depression, depressed mood and decreased interest

In another placebo-controlled clinical trial of patients
with carcinoid syndrome diarrhea and less than 4 bowel movements per day, the
following additional adverse reactions, not listed in Table 1, of abdominal
pain (including upper and lower abdominal pain, abdominal distention and gastrointestinal
pain) and constipation were reported in at least 5% of patients in the Xermelo
treated group and at an incidence greater than placebo.

Less Common Adverse Reactions

The following is a list of adverse reactions occurring in
less than 5% of patients receiving Xermelo during the 12-week
placebo-controlled period of the clinical trial:

Investigations: increased alkaline phosphatase,
increased alanine aminotransferase, and increased aspartate aminotransferase.

Fecaloma was reported in one patient treated with Xermelo
during the 36-week open-label extension period following the 12-week
double-blind period of the trial.

What is the dosage for Survanta?

The recommended dosage of Xermelo in adult patients is 250 mg three times daily for patients whose diarrhea is inadequately controlled by SSA therapy.

Administration

  • Take Xermelo with food.
  • When short-acting octreotide is used in combination with Xermelo, administer shortacting octreotide at least 30 minutes after administering Xermelo.
  • If a dose is missed, take the next dose at the regular time. Do not take 2 doses at the same time to make up for a missed dose.
  • Discontinue Xermelo if severe constipation develops.

What drugs interact with Survanta?

CYP3A4 Substrates

  • Concomitant use of Xermelo may decrease the efficacy of drugs that are
    CYP3A4 substrates (e.g., midazolam) by decreasing their systemic exposure.
  • Monitor for suboptimal efficacy and consider increasing the dose for
    concomitant CYP3A4 substrates, if necessary.

Short-Acting Octreotide

  • Concurrent administration of short-acting octreotide with Xermelo
    significantly decreased the systemic exposure of telotristat ethyl and
    telotristat, the active metabolite.
  • If treatment with short-acting octreotide is needed in combination with
    Xermelo, administer short-acting octreotide at least 30 minutes after
    administration of Xermelo.

Is Survanta safe to use while pregnant or breastfeeding?

  • There are no human data with Xermelo use in pregnant women to inform a drug-associated risk.
  • There are no data on the presence of telotristat ethyl in human or animal milk, the effects on the breastfed infant, or the effects on milk production.
  • The effects of local gastrointestinal and systemic exposure to telotristat ethyl on breastfed infants are unknown.
  • The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Xermelo and any potential adverse effects on the breastfed infant from Xermelo or from the underlying maternal condition.




SLIDESHOW


Skin Cancer Symptoms, Types, Images
See Slideshow

Medically Reviewed on 11/5/2020

References


All sections courtesy of the U.S. Food and Drug Administration



Source link

Share and Enjoy !

0Shares
0 0
Close