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SUNLENCA is a brand name for Lenacapavir, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: SUNLENCA (lenacapavir), in combination with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance or…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • Initiation of treatment requires SUNLENCA injection to be given with SUNLENCA tablets. • Prior to starting SUNLENCA, health professionals should counsel patients about the importance of adherence to scheduled dosing visits to help maintain viral suppression, reduce the risk of viral rebound and potential development of resistance with missed doses (see 7 WARNINGS AND PRECAUTIONS).
2 Recommended Dose and Dosage Adjustment The recommended SUNLENCA treatment regimen in adults consists of an initiation dosing period (oral tablets and subcutaneous injections) and twice yearly (once every 6-months) maintenance dosing (subcutaneous injections).
SUNLENCA oral tablets may be taken with or Product Monograph Page 5 of 36 <SUNLENCA> lenacapavir* injection and tablets *as lenacapavir sodium without food. • Initiation: On treatment Day 1 and Day 2, the recommended dose of SUNLENCA is 600 mg per day (2 x 300 mg tablets) taken orally.
On treatment Day 8, the recommended dose is 300 mg taken orally. 5 mL injections) administered by subcutaneous injection. 5 mL injections) of SUNLENCA administered by subcutaneous injection every 6 months (26 weeks) from the date of last injection (+/- 2 weeks) (see Table 1).
Table 1. 5 mL injections)a a. Two injections, each at a separate site in the abdomen b. From the date of last injection. If a patient vomits within 3 hours after taking SUNLENCA tablets, the patient should take an extra oral dose, and the scheduled dosing regimen should continue.
If a patient vomits more than 3 hours after taking SUNLENCA tablets, the patient should not take an extra oral dose of SUNLENCA tablets, and the scheduled dosing regimen should continue. 1 Pediatrics). Geriatrics (> 65 years of age) No dose adjustment of SUNLENCA is required for elderly patients.
Clinical studies of SUNLENCA did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from adult patients < 65 years of age. Renal Impairment No dose adjustment of SUNLENCA is required in patients with mild, moderate, or severe renal impairment (CrCl ≥15 mL/min).
SUNLENCA has not been studied in patients with end stage renal disease (ESRD), therefore it should be administered with caution in these patients. Product Monograph Page 6 of 36 <SUNLENCA> lenacapavir* injection and tablets *as lenacapavir sodium Hepatic Impairment No dose adjustment of SUNLENCA is required in patients with mild or moderate hepatic impairment (Child-Pugh Class A or B).
1 Adverse Reaction Overview The following adverse drug reactions are discussed in WARNINGS AND PRECAUTIONS: • Immune Reconstitution Inflammatory Syndrome (see 7 WARNINGS AND PRECAUTIONS) The overall safety population reflects exposure to SUNLENCA in 229 patients with HIV.
The primary safety analysis is based on the pivotal study (GS-US-200-4625 [CAPELLA]; N=72), which was conducted in heavily treatment experienced adult patients with HIV who received SUNLENCA in a Phase 2/3 trial through Week 26 (median duration on study of 32 weeks) and Week 52 (median duration on study of 54 weeks) (see 14 CLINICAL TRIALS).
Supportive data was provided in treatment-naïve adult patients with HIV who received SUNLENCA in a Phase 2 trial (GS-US-200-4334 [CALIBRATE]; N=157) through Week 28 (median duration of exposure of 43 weeks) and Week 54 (median duration on study of 66 weeks).
In CAPELLA, a treatment-emergent adverse event (TEAE) was reported in 93% of patients. Excluding injection site reactions (ISR), the most common TEAEs reported in ≥5% of patients were diarrhea, nausea, COVID-19, abdominal distension, constipation, cough, arthralgia, back pain, headache, pyrexia, urinary tract infection, rash, dizziness, fatigue, oral candidiasis and vomiting.
The majority of these events were Grade 1 or Grade 2 and resolved without discontinuation or interruption of study medication. 7%, 48 patients. 2%) had Grade 3 or higher AEs. 8%, 2 patients each). Four patients experienced Grade 3 or higher AEs that were considered related to study drug by the study investigator: rash and abdominal abscess, injection site swelling and injection site erythema, injection site pain, and Product Monograph Page 12 of 36 <SUNLENCA> lenacapavir* injection and tablets *as lenacapavir sodium immune reconstitution inflammatory syndrome (1 participant each).
1%). None were considered related to the study drug. 4%) discontinued study drug due to an AE of an ISR beyond Week 52. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials, therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
). 2 Recommended Dose and Dosage Adjustment The recommended SUNLENCA treatment regimen in adults consists of an initiation dosing period (oral tablets and subcutaneous injections) and twice yearly (once every 6-months) maintenance dosing (subcutaneous injections).
SUNLENCA oral tablets may be taken with or Product Monograph Page 5 of 36 <SUNLENCA> lenacapavir* injection and tablets *as lenacapavir sodium without food. • Initiation: On treatment Day 1 and Day 2, the recommended dose of SUNLENCA is 600 mg per day (2 x 300 mg tablets) taken orally.
On treatment Day 8, the recommended dose is 300 mg taken orally. 5 mL injections) administered by subcutaneous injection. 5 mL injections) of SUNLENCA administered by subcutaneous injection every 6 months (26 weeks) from the date of last injection (+/- 2 weeks) (see Table 1).
Table 1. 5 mL injections)a a. Two injections, each at a separate site in the abdomen b. From the date of last injection. If a patient vomits within 3 hours after taking SUNLENCA tablets, the patient should take an extra oral dose, and the scheduled dosing regimen should continue.
If a patient vomits more than 3 hours after taking SUNLENCA tablets, the patient should not take an extra oral dose of SUNLENCA tablets, and the scheduled dosing regimen should continue. 1 Pediatrics). Geriatrics (> 65 years of age) No dose adjustment of SUNLENCA is required for elderly patients.
Clinical studies of SUNLENCA did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from adult patients < 65 years of age. Renal Impairment No dose adjustment of SUNLENCA is required in patients with mild, moderate, or severe renal impairment (CrCl ≥15 mL/min).
SUNLENCA has not been studied in patients with end stage renal disease (ESRD), therefore it should be administered with caution in these patients. Product Monograph Page 6 of 36 <SUNLENCA> lenacapavir* injection and tablets *as lenacapavir sodium Hepatic Impairment No dose adjustment of SUNLENCA is required in patients with mild or moderate hepatic impairment (Child-Pugh Class A or B).
• Concomitant administration with the following is contraindicated due to decreased lenacapavir plasma concentrations, which may result in the loss of therapeutic effect and development of resistance to SUNLENCA, see 9 DRUG INTERACTIONS.
o anticonvulsants: carbamazepine, phenytoin o antimycobacterials: rifampin, rifapentine o St. John’s wort • SUNLENCA is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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SUNLENCA has not been studied in patients with severe hepatic impairment (Child-Pugh Class C), therefore it should be administered with caution in these patients. 3 Administration SUNLENCA injection is only for subcutaneous administration into the abdomen by a health professional.
Do NOT administer intradermally (see 7 WARNINGS AND PRECAUTIONS). Use aseptic technique. No reconstitution of the injectable solution is required prior to administration. Visually inspect the solution in the vials for particulate matter and discoloration prior to administration.
SUNLENCA injection is yellow to brown solution. Do not use SUNLENCA injection if the solution is discolored or if it contains particulate matter. Once the solution is withdrawn from the vials, the subcutaneous injections should be administered as soon as possible (see 11 STORAGE, STABILITY AND DISPOSAL).
Refer to Figure 1 to identify the components for use in the administration steps. The administration steps are provided in Figure 2. The injection kit components are for single use only. Use of vial access device is required. 5 mL injections are required for a complete dose.
Product Monograph Page 7 of 36 <SUNLENCA> lenacapavir* injection and tablets *as lenacapavir sodium Figure 1. SUNLENCA Injection Kit Components Figure 2. , 26 weeks + 2 weeks window) have elapsed since the last injection and if clinically appropriate to continue SUNLENCA treatment, restart the initiation dosage regimen from Day 1 (see Table 1).
, Day 1), the entire dosing regimen shifts by the number of days delayed. Recommendations for missed Day 2 and Day 8 oral tablet doses are provided in Table 2. Product Monograph Page 8 of 36 <SUNLENCA> lenacapavir* injection and tablets *as lenacapavir sodium Table 2.
Recommendations for Missed Day 2 and Day 8 Oral Doses Days Elapsed Since Missed Dose Recommendations If the Day 2 (600 mg) oral dose is missed by: less than 6 days Take 600 mg as soon as possible, and 300 mg on Day 8. 6 days or more Take 600 mg as soon as possible, and 300 mg on Day 15.
If the Day 8 (300 mg) oral dose is missed by: less than 6 days Take 300 mg soon as possible. 6 days or more Take 300 mg on Day 15. Regardless of when the Day 2 or Day 8 oral dose is being taken, subcutaneous injection should be administered on Day 15 as described in Table 1.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. The most common adverse reactions (all Grades) reported in at least 3% of patients in CAPELLA were nausea and injection site reactions.
Table 4 displays the frequency of adverse reactions (all Grades) ≥3% in the SUNLENCA group. Table 4. Adverse Reactions (All Grades) Reported in ≥3%a of Heavily Treatment Experienced Adults with HIV-1 Receiving SUNLENCA in CAPELLA (Week 26 and 52 Analysis) Week 26 Week 52 Adverse Reactions SUNLENCA + Background Regimen (N=72) SUNLENCA + Background Regimen (N=72) GASTROINTESTINAL DISORDERS Nausea 4% 4% GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection Site Reactions 56% 63%b a.
Frequencies of adverse reactions are based on all treatment-emergent adverse events attributed to study drug by the investigator, based on all patients (cohorts 1 and 2) in CAPELLA. b. Includes injection site swelling, erythema, pain, nodule, induration, pruritus, discomfort, mass, extravasation, hematoma, edema and ulcer.
Median (Q1, Q3) duration of injection site reactions (ISR) was 8 (3, 67) days. Of the 45 patients who experienced a study drug related ISR, majority [67% (30/45)] had Grade 1 ISRs. Most (97%) of the adverse events associated with SUNLENCA were mild or moderate in severity.
No patients who received SUNLENCA in CAPELLA experienced serious adverse events related to study drug. 3 Less Common Clinical Trial Adverse Reactions Adverse reactions occurring in 2 or more patients administered SUNLENCA beyond those included in Table 4 are presented below.
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data Clinical Trial Findings The frequency of selected laboratory abnormalities (Grades 3 to 4) occurring in at least 3% of patients in CAPELLA are presented in Table 5.
A causal association between SUNLENCA and these laboratory abnormalities has not been established. Table 5. 9 mmol/L) 5% 6% Glycosuria (>2+) 6% 6% ULN = upper limit of normal a. Frequencies are based on treatment-emergent laboratory abnormalities in all patients (cohorts 1 and 2) in CAPELLA.
Percentages were calculated based on the number of patients with post-baseline toxicity grades for each laboratory parameter (n=72 for all parameters except hyperglycemia fasting n=55).
SUNLENCA has not been studied in patients with severe hepatic impairment (Child-Pugh Class C), therefore it should be administered with caution in these patients. 3 Administration SUNLENCA injection is only for subcutaneous administration into the abdomen by a health professional.
Do NOT administer intradermally (see 7 WARNINGS AND PRECAUTIONS). Use aseptic technique. No reconstitution of the injectable solution is required prior to administration. Visually inspect the solution in the vials for particulate matter and discoloration prior to administration.
SUNLENCA injection is yellow to brown solution. Do not use SUNLENCA injection if the solution is discolored or if it contains particulate matter. Once the solution is withdrawn from the vials, the subcutaneous injections should be administered as soon as possible (see 11 STORAGE, STABILITY AND DISPOSAL).
Refer to Figure 1 to identify the components for use in the administration steps. The administration steps are provided in Figure 2. The injection kit components are for single use only. Use of vial access device is required. 5 mL injections are required for a complete dose.
Product Monograph Page 7 of 36 <SUNLENCA> lenacapavir* injection and tablets *as lenacapavir sodium Figure 1. SUNLENCA Injection Kit Components Figure 2. , 26 weeks + 2 weeks window) have elapsed since the last injection and if clinically appropriate to continue SUNLENCA treatment, restart the initiation dosage regimen from Day 1 (see Table 1).
, Day 1), the entire dosing regimen shifts by the number of days delayed. Recommendations for missed Day 2 and Day 8 oral tablet doses are provided in Table 2. Product Monograph Page 8 of 36 <SUNLENCA> lenacapavir* injection and tablets *as lenacapavir sodium Table 2.
Recommendations for Missed Day 2 and Day 8 Oral Doses Days Elapsed Since Missed Dose Recommendations If the Day 2 (600 mg) oral dose is missed by: less than 6 days Take 600 mg as soon as possible, and 300 mg on Day 8. 6 days or more Take 600 mg as soon as possible, and 300 mg on Day 15.
If the Day 8 (300 mg) oral dose is missed by: less than 6 days Take 300 mg soon as possible. 6 days or more Take 300 mg on Day 15. Regardless of when the Day 2 or Day 8 oral dose is being taken, subcutaneous injection should be administered on Day 15 as described in Table 1.
5 OVERDOSAGE If overdose occurs, the patient must be monitored for evidence of toxicity. Treatment of overdose with SUNLENCA consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient.
As lenacapavir is highly protein bound, it is unlikely to be significantly removed by dialysis. For management of a suspected drug overdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 3.
Dosage Forms, Strengths, Composition and Packaging SUNLENCA injection is a sterile, preservative-free, clear, yellow to brown solution with no visible particles. SUNLENCA injection is […]