SUNLENCA 300 MG — DIN 02532468
LENACAPAVIR (LENACAPAVIR SODIUM) : 300 MG · GILEAD SCIENCES CANADA INC · TABLET · wholesale supply in Canada
Health Canada status: MARKETED
What is SUNLENCA?
SUNLENCA 300 MG contains LENACAPAVIR (LENACAPAVIR SODIUM) : 300 MG. It is listed in the Health Canada Drug Product Database under DIN 02532468, held by GILEAD SCIENCES CANADA INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 15-Mar-2023. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.
What is SUNLENCA 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 safety considerations.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
How much does Lenacapavir cost around the world?
Lenacapavir is listed on 3 of the national price registers Nexara ingests. Each country publishes on a different basis, so figures are not comparable with one another — or with a Canadian wholesale price.
What a market publishes matters more than the number it publishes. Iceland publishes a max wholesale; Italy publishes a ex-factory (classe H); Saudi Arabia publishes a public. Comparing an ex-factory ceiling against a pharmacy public price tells you nothing about either, and comparing either against a Canadian landed cost tells you less.
| Market | Price basis published there | Brands | Packs listed |
|---|---|---|---|
| Saudi Arabia | public | 2 | 3 |
| Iceland | max wholesale | 1 | 2 |
| Italy | ex-factory (classe H) | 2 | 2 |
7 pack listings across 5 brand entries and 3 price bases, refreshed 02 Sep 2026. Ranges span every Lenacapavir pack in that market, so a high figure is usually a larger pack rather than the same product.
Canada publishes no comparable public list price. For a delivered Canadian price on a licensed account, verify your licence — it takes about a minute.
Is there a generic Lenacapavir in Canada, and who makes it?
Every market authorization holder with a Canadian DIN for this molecule, and how many of their listings Health Canada currently shows as marketed.
Only one market authorization holder has a Canadian DIN containing Lenacapavir — 2 DINs, of which 2 are currently marketed. There is no second Canadian source today, so a supply interruption on this holder has no domestic substitute at the same molecule.
| Market authorization holder | DINs | Marketed | Brand names | Position |
|---|---|---|---|---|
| GILEAD SCIENCES CANADA INC | 2 | 2 | SUNLENCA | Sourceable in Canada |
Health Canada’s Drug Product Database does not flag which listing is the originator and which are subsequent-entry products, so Nexara does not label them here. Interchangeability is determined provincially, not federally — confirm for your province before a formulary switch. Nexara can confirm which of these is actually obtainable, and on what lead time, per order.
How is it supplied and stored?
Pack configuration, storage class and the handling constraints that drive cold-chain planning. One DIN can cover more than one pack size, and the pack — not the DIN — is what gets priced, shipped and invoiced.
| Strength on the label | 300 MG |
|---|---|
| Dosage form | TABLET |
| Route | ORAL |
| Pack configuration (monograph) | SUNLENCA injection is packaged in a dosing kit containing: * 2 single-use clear glass vials of SUNLENCA, each containing sufficient volume to allow withdrawal of 1.5 mL/463.5 mg (309 mg/mL) of lenacapavir. Vials are sealed with an elastomeric closure and aluminum overseal with flip-off cap. * 2 vial access devices, 2 disposable syringes, and 2 injection safety needles for subcutaneous injection (22-gauge, 1½ inch). SUNLENCA tablets are packaged in a blister pack containing: * 5 tablets of SUNLENCA, each containing 300 mg of lenacapavir, in a clear blister film sealed to a foil lidding material. The blister card, which is fitted between child-resistant sealed paperboard cards, is packaged with silica gel desiccant in a sealed flexible laminated pouch. |
| Storage | SUNLENCA injection: Store in the original package. Store below 30 °C. Keep the vials in the original carton until just prior to preparation of the injections in order to protect them from light. Once the solution has been drawn into the syringes, the injections should be administered as soon as possible. SUNLENCA tablets: Store in the original package. Store below 30 °C. Protect from light. Keep out of reach and sight of children. |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Substance and classification
| Active substance | Lenacapavir |
|---|---|
| ATC code | J05AX31 |
| AHFS class | 04:04.04 |
| Biosimilar biologic | No |
Health Canada record and identifiers
The regulatory facts straight from the Drug Product Database, plus every identifier form Nexara accepts on a purchase order. A DIN written without its leading zeros is the commonest reason an order line fails to match.
| DIN (8-digit, as used in ordering) | 02532468 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2532468 |
| Brand name | SUNLENCA |
| Generic / active ingredient | LENACAPAVIR (LENACAPAVIR SODIUM) : 300 MG |
| Market authorization holder | GILEAD SCIENCES CANADA INC |
| Health Canada schedule | Prescription |
| ATC code | J05AX31 |
| ATC anatomical main group | J — Anti-infectives for systemic use |
| ATC therapeutic subgroup | J05AX |
| Current status | MARKETED |
| Status date | 15-Mar-2023 |
| Original market date | 2023-03-23 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
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 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. Then, on treatment Day 15, the recommended dose is 927 mg (2 x 1.5 mL injections) administered by subcutaneous injection. Maintenance: The recommended dose is 927 mg (2 x 1.5 mL injections) of SUNLENCA administered by subcutaneous injection every 6 months (26 weeks) from the date of last injection (+/- 2 weeks). 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. SUNLENCA injection is only for subcutaneous administration into the abdomen by a health professional. Do NOT administer intradermally. 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. Missed Dose: During the maintenance period, if more than 28 weeks (i.e., 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. If a patient misses the first oral dose on the scheduled date (i.e., 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.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
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: * anticonvulsants: carbamazepine, phenytoin * antimycobacterials: rifampin, rifapentine * 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.
Warnings and precautions
Patients with low CD4 count receiving SUNLENCA or any other antiretroviral therapy may still develop opportunistic infections and other complications of HIV infection. Therefore, patients should remain under close clinical observation by a health professional experienced in the treatment of these associated HIV diseases. Immune Reconstitution Inflammatory Syndrome: Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy. During the initial phase of combination antiretroviral treatment, patients whose immune system responds may develop an inflammatory response to indolent or residual opportunistic infections, which may necessitate further evaluation and treatment. Autoimmune disorders have also been reported to occur in the setting of immune reconstitution; however, the reported time to onset is more variable, and these events can occur many months after initiation of treatment. Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions: The concomitant use of SUNLENCA and certain other drugs may result in known or potentially significant drug interactions, some of which may increase a risk of adverse reactions due to increased lenacapavir exposure or lead to loss of therapeutic effect of SUNLENCA and possible development of resistance due to reduced exposure of lenacapavir. Consider the potential for drug interactions prior to and during therapy with SUNLENCA, review concomitant medications during therapy with SUNLENCA, and monitor for the adverse reactions associated with the concomitant drugs. Risk of Resistance Due to Treatment Discontinuation: It is important to counsel patients regarding the required 6-monthly injection maintenance dosing schedule because non-adherence to scheduled dosing visits could lead to loss of virologic response and the development of resistance. If SUNLENCA is discontinued, to minimize the risk of developing viral resistance it is essential to adopt an alternative, fully suppressive antiretroviral regimen where possible, no later than 28 weeks after the final injection of SUNLENCA. Use of Other Drugs After Discontinuation of SUNLENCA: Due to the long-acting characteristics of lenacapavir, if SUNLENCA is discontinued, residual concentrations of lenacapavir may remain in the systemic circulation of patients for prolonged periods. These concentrations may affect the exposures of other drugs (ie, sensitive CYP3A substrates) that are initiated within 9 months after the last subcutaneous dose of SUNLENCA. These concentrations are not expected to affect the exposures of other antiretroviral agents that are initiated after discontinuation of SUNLENCA. Injection Site Reactions with Improper Administration: Improper administration (intradermal injection) has been associated with serious injection site reactions, including necrosis and ulcer. Ensure SUNLENCA is administered subcutaneously.
What can be used instead?
Alternatives on every axis a buyer actually considers — the same molecule in another presentation, the same class, an adjacent class, or a fixed-dose combination. Every row is led by the marketed DIN count, because that is what can be bought this week.
1 · Same molecule, other Canadian presentations
2 of 2 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| SUNLENCA | 309 MG | SOLUTION | GILEAD SCIENCES CANADA INC | MARKETED | 02532476 |
2 · Same class — other molecules in ATC J05AX
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Baloxavir Marboxil | XOFLUZA | 3 | 3 | Yes |
| Other Antivirals | PREVYMIS | 2 | 2 | Yes |
| Lenacapavir | SUNLENCA | 2 | 2 | Yes |
| Maraviroc | CELSENTRI | 2 | 2 | Yes |
| Inosine Pranobex | IMUNOVIR · ISOPRINOSINE · ISOPRINOSINE TAB 500MG | 4 | 1 | Yes |
| Letermovir | PREVYMIS | 2 | 1 | Yes |
| Maribavir | LIVTENCITY | 1 | 1 | Yes |
| Bulevirtide | HEPCLUDEX | 1 | 1 | Yes |
| Fostemsavir | RUKOBIA | 1 | 1 | Yes |
| Enfuvirtide | FUZEON | 1 | 0 | Not in Canada |
A molecule with zero marketed DINs cannot be sourced domestically, however many approvals it holds — if one of these sits on a formulary or in an older protocol, that is the line to check.
3 · Adjacent classes in ATC J05A
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| J05AB | Acyclovir · Brincidofovir · Cidofovir · Famciclovir · Ganciclovir · +3 more | 143 | 55 |
| J05AR | Antivirals For Treatment Of Hiv Infections, Combinations · Atanazavir And Cobicistat · Darunavir And Cobicistat · Dolutegravir And Rilpivirine · Emtricitabine And Tenofovir Alafenamide · +16 more | 56 | 39 |
| J05AF | Abacavir · Adefovir Dipivoxil · Didanosine · Emtricitabine · Entecavir · +7 more | 71 | 39 |
| J05AH | Neuraminidase Inhibitors · Oseltamivir · Zanamivir | 33 | 16 |
| J05AE | Amprenavir · Atazanavir · Darunavir · Fosamprenavir · Indinavir · +5 more | 75 | 14 |
| J05AG | Delavirdine · Doravirine · Efavirenz · Etravirine · Nevirapine · +1 more | 22 | 10 |
| J05AJ | Cabotegravir · Dolutegravir · Elvitegravir · Raltegravir | 12 | 6 |
| J05AP | Asunaprevir · Boceprevir · Daclatasvir · Dasabuvir, Ombitasvir, Paritaprevir And Ritonavir · Elbasvir And Grazoprevir · +8 more | 22 | 6 |
Not clinical advice. These tables describe what can be supplied in Canada, not what should be prescribed. Substitution within or across classes is a prescriber and pharmacist decision, and interchangeability is determined provincially.
What else is SUNLENCA called?
Also recorded in Canada as: LENACAPAVIR (GLOBAL), LENACAPAVIR SODIUM (US), LENACAPAVIR SODIUM (UK).
How can I get it?
Nexara Health supplies this product to licensed Canadian buyers — pharmacies, hospitals, clinics, licensed distributors, and clinical trial sponsors or their CROs. We confirm stock, pack size, expiry and pricing at the time of quotation. If the product is on backorder or in shortage, we identify equivalent alternatives and import options where permitted.
Ordering questions
Who can buy this from Nexara?
Licensed entities only. Nexara holds Health Canada establishment licence DEL 3-002896-A and ships only to a licensed address. Patients and unlicensed buyers are routed to a partner pharmacy.
Is there a minimum order?
Yes, set per product line and per pack multiple rather than on the order total, so you are never asked to buy a part-pack. The minimum for this line is confirmed with your quote.
What is the lead time?
Confirmed per order at quotation, and it depends on current stock position and whether the product is in shortage.
Why is there no price on this page?
Nexara quotes a delivered Canadian price per order, against a verified licence. Foreign list prices are published on incompatible bases and are not a guide to what any buyer can obtain here, so this page shows which markets list the molecule and on what basis, and nothing more.
Can Nexara supply this for a clinical trial?
Yes — comparator and background-therapy supply, including sourcing from other markets where a Canadian pack will not satisfy the protocol. Clinical trial supply.