imetelstat

High Alert

Low to intermediate-1 risk myelodysplastic syndromes in patients with transfusion-dependent anemia requiring ≥4 RBC units over 8 wk who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents.

Contraind./Precautions ⬆ ⬇

Contraindicated in:

OB: Pregnancy;
Lactation: Lactation.

Use Cautiously in:

Rep: Women of reproductive potential;
Pedi: Safety and effectiveness not established in children.

Adv. Reactions/Side Effects ⬆ ⬇

CV: atrial fibrillation/flutter

Derm: pruritus

EENT: epistaxis

GI: ↑liver enzymes

GU: ↓fertility (women), urinary tract infection

Hemat: ↑activated partial thromboplastin time, leukopenia, neutropenia, thrombocytopenia, hematoma

MS: arthralgia, myalgia, fracture

Neuro: fatigue, headache, syncope

Misc: INFUSION-RELATED REACTIONS

Interactions ⬆ ⬇

Drug-drug:

None reported.

Availability ⬆ ⬇

Lyophilized powder for injection: 47 mg/vial; 188 mg/vial

Route/Dosage ⬆ ⬇

IV (Adults ): 7.1 mg/kg every 4 wk. Discontinue if patient does not experience ↓ RBC transfusions after 24 wk of treatment (6 doses) or if unacceptable toxicity occurs at any time.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Acts as a telomerase inhibitor, which reduces malignant stem and progenitor cell proliferation and apoptosis.

Therapeutic effects:

Reduction of RBC transfusions.

Classifications ⬆ ⬇

Therapeutic Classification: antineoplastics

Pharmacologic Classification: temporary class

Pharmacokinetics ⬆ ⬇

Absorption: IV administration results in complete bioavailability.

Distribution: Minimally distributed to tissues.

Protein Binding: >94%.

Metabolism/Excretion: Metabolized by nucleases to nucleotides.

Half-Life: 4.9 hr.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
IV	rapid	end of infusion	unknown

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication. Advise patient to read Patient Information before starting therapy. Emphasize the importance of routine laboratory testing.
Advise patient to notify health care provider of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care provider before taking other medications.
Advise patient of signs/symptoms of liver dysfunction such as jaundice, abdominal pain, and dark-colored urine.
Advise patient about signs/symptoms of thrombocytopenia such as unusual bleeding or bruising and to notify health care provider immediately if symptoms occur.
Advise patient about infection prevention strategies such as hand hygiene, avoidance of crowds, wearing a mask in public, and avoiding raw foods and fresh flowers if neutropenic.
Advise patient of infusion-related reactions, to report signs/symptoms to health care provider immediately, and to seek immediate medical attention if needed.
Encourage a diet rich in iron and protein to support RBC production.
Rep: Advise women of reproductive potential to notify health care provider if pregnancy is planned or suspected. Advise women of reproductive potential to use effective contraception during therapy and for 1 wk after the last dose. Advise women not to breastfeed during therapy and for 1 wk after the last dose.

Pronunciation ⬆ ⬇

Code ⬆

NDC Code

61434- Catalent Indiana, LLC
- 61434-069-
  - 61434-069-00- 288 VIAL in 1 CASE (61434-069-00) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

68225- Patheon Italia S.p.A.
- 68225-248-
  - 68225-248-00- 170 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 TRAY (68225-248-00)

73675- ST Pharm Co., Ltd.
- 73675-003-
  - 73675-003-01- 1 BOTTLE in 1 BAG (73675-003-01) / 594 g in 1 BOTTLE

82959- Geron Corporation
- 82959-111- RYTELO
  82959-111-01- 1 VIAL, SINGLE-DOSE in 1 CARTON (82959-111-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

82959- Geron Corporation
- 82959-112- RYTELO
  - 82959-112-01- 1 VIAL, SINGLE-DOSE in 1 CARTON (82959-112-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

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Indications ⬇