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Kadcyla Powder for Concentrate for Solution for Infusion 100 mg

NAFDAC Reg. No. A6-0506 · Drug

Registered with NAFDAC. Registration activeAs of 27 October 2026 · synced automatically from official sources.
Product
Kadcyla Powder for Concentrate for Solution for Infusion 100 mg
NAFDAC number
A6-0506
Active ingredient
Trastuzumab emtansine
Strength
100 mg/5 mL
Form
Powder for concentrate for solution for infusion
Pack size
100 mg x 1's (in vial)
Manufacturer
Not listed
Applicant (holder)
Roche Products Limited
Approved
6 Jun 2023
Status
Active View on NAFDAC ↗
Registration valid to
30 May 2028
WHO alerts
None found
Community reports
None
Times checked
0

What we found

  • Kadcyla Powder for Concentrate for Solution for Infusion 100 mg is on the NAFDAC register with an active registration (A6-0506). A valid number alone does not prove a pack is genuine — counterfeiters copy real numbers, so also check the expiry date, seal and print quality.

Generated automatically from the NAFDAC register, WHO alerts and community data as of today. This is not medical advice. Always follow your doctor or pharmacist.

What Kadcyla Powder for Concentrate for Solution for Infusion 100 mg is used for

From the official U.S. FDA label for trastuzumab emtansine, the active ingredient registered with NAFDAC.

Boxed warning: HEPATOTOXICITY, CARDIAC TOXICITY, EMBRYO-FETAL TOXICITY Hepatotoxicity: Serious hepatotoxicity has been reported, including liver failure and death in patients treated with KADCYLA. Monitor serum transaminases and bilirubin prior to initiation of KADCYLA treatment and prior to each KADCYLA dose. Reduce dose or discontinue KADCYLA as appropriate in cases of increased serum transaminases or total bilirubin. …
What it is used for

KADCYLA is a HER2-targeted antibody and microtubule inhibitor conjugate indicated, as a single agent, for: the treatment of patients with HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either: received prior therapy for metastatic disease, or developed disease recurrence during or within six months of completing adjuvant therapy. ( 1.1 ) the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment. …

Possible side effects

The following adverse reactions are discussed in greater detail in other sections of the label: Hepatotoxicity [See Warnings and Precautions (5.1) ] Left Ventricular Dysfunction [See Warnings and Precautions (5.2) ] Embryo-Fetal Toxicity [See Warnings and Precautions (5.3) ] Pulmonary Toxicity [See Warnings and Precautions (5.4) ] Infusion-Related Reactions, Hypersensitivity Reactions [See Warnings and Precautions (5.5) ] Hemorrhage [See Warnings and Precautions (5.6) ] Thrombocytopenia [See Warnings and Precautions (5.7) ] Neurotoxicity [See Warnings and Precautions (5.8) ] Metastatic Breast Cancer The most common adverse reactions (≥ 25%) with KADCYLA were fatigue, nausea, musculoskeletal …

Do not use if

None. None. ( 4 )

Warnings

Pulmonary Toxicity: Permanently discontinue KADCYLA in patients diagnosed with interstitial lung disease or pneumonitis. For patients with radiation pneumonitis in the adjuvant setting, permanently discontinue KADCYLA for Grade ≥ 3 or for Grade 2 not responding to standard treatment. ( 2.2 , 5.4 ) Infusion-Related Reactions, Hypersensitivity Reactions: Monitor for signs and symptoms during and after infusion. If significant infusion-related reactions or hypersensitivity reactions occur, slow or interrupt the infusion and administer appropriate medical therapies. Permanently discontinue KADCYLA for life threatening infusion-related reaction. …

Pregnancy & breastfeeding

8.1 Pregnancy If KADCYLA is administered during pregnancy, or if a patient becomes pregnant while receiving KADCYLA or within 7 months following the last dose of KADCYLA, health care providers and patients should immediately report KADCYLA exposure to Genentech at 1-888-835-2555. Risk Summary KADCYLA can cause fetal harm when administered to a pregnant woman. There are no available data on the use of KADCYLA in pregnant women. …

Storage

16.1 How Supplied/Storage KADCYLA (ado-trastuzumab emtansine) is supplied as: Carton Contents NDC One 100 mg vial, single-dose vial NDC 50242-088-01 One 160 mg vial, single-dose vial NDC 50242-087-01 Store vials in a refrigerator at 2°C to 8°C (36°F …

General information only, not dosing advice. Always follow the leaflet in your pack and your doctor or pharmacist.

Check your pack of Kadcyla Powder for Concentrate for Solution for Infusion 100 mg

Add the expiry date on your pack for a full Trust Score.

3 free checks left today Official sources: NAFDAC Green Book & recalls · WHO · U.S. FDA · NLM RxNorm

About Kadcyla Powder for Concentrate for Solution for Infusion 100 mg

What is in Kadcyla Powder for Concentrate for Solution for Infusion 100 mg?

Kadcyla Powder for Concentrate for Solution for Infusion 100 mg contains Trastuzumab emtansine (100 mg/5 mL), as powder for concentrate for solution for infusion, according to its NAFDAC registration record.

Is Kadcyla Powder for Concentrate for Solution for Infusion 100 mg registered with NAFDAC?

Yes. Kadcyla Powder for Concentrate for Solution for Infusion 100 mg is listed on the NAFDAC register under registration number A6-0506, and its registration is active as of 27 October 2026.

Has Kadcyla Powder for Concentrate for Solution for Infusion 100 mg been flagged as fake or recalled?

No WHO falsified or substandard medical product alert currently matches Kadcyla Powder for Concentrate for Solution for Infusion 100 mg in our automatically synced alert list.

How can I check that my pack of Kadcyla Powder for Concentrate for Solution for Infusion 100 mg is genuine?

Run a free authenticity scan with the NAFDAC number A6-0506, your pack's expiry date and batch number to get a Trust Score, compare the pack with the NAFDAC record (ingredient, strength, form, manufacturer), and buy only from licensed pharmacies.

What is Kadcyla Powder for Concentrate for Solution for Infusion 100 mg used for?

KADCYLA is a HER2-targeted antibody and microtubule inhibitor conjugate indicated, as a single agent, for: the treatment of patients with HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either: received prior therapy for metastatic disease, or developed disease recurrence during or within six months of com (Summarised from the official U.S. FDA label for trastuzumab emtansine. Always follow your doctor or pharmacist.)

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Reviews are personal experiences from PillVera users, not medical advice. Report side effects to your doctor and to NAFDAC.