SIGRIMA™, in some cases, may lead to cardiovascular (heart) problems,which may or may not cause symptoms. For example, congestive heart failure and decreased function of the heart.^2,3

Your doctor may test your heart health before treating with SIGRIMA™ and will also monitor your heart function throughout the treatment. Based on the test results, your doctor may stop or pause the treatment with SIGRIMA™.

If you experience any of the following symptoms with SIGRIMA™, seek professional help immediately: difficulty breathing (new onset or worsening of existing condition), face/ankle/leg swelling, heart palpitations, feeling dizzy, sudden excess weight gain (>2.2 kg) in 1 day, or loss of consciousness.⁴

It is recommended to use birth control during your treatment with SIGRIMA™, which should be continued for 7 months after your last SIGRIMA™ dose.⁴

For breastfeeding women, it is important to talk to a doctor regarding the discontinuation of breastfeeding while on SIGRIMA™ or pausing treatment with SIGRIMA™.⁵

During your course of treatment with SIGRIMA™, if you are worried you might be pregnant, you should seek professional advice immediately.

You should not use SIGRIMA™ if you’re allergic to Pertuzumab or other ingredients found in SIGRIMA™. SIGRIMA™ is delivered via a needle directly into your vein⁴, which is why it can be linked to infusion-related reactions that may or may not be fatal in nature.⁷ Commonly observed reactions when receiving SIGRIMA™ + Trastuzumab + docetaxel include ^4,8:

• Tiredness
• Allergic reactions
• Muscle pain
• Vomiting

Commonly observed reactions when receiving ONLY SIGRIMA™ include,⁴:

• Fever and chills
• Headache
• Weakness
• Allergic reactions
• Vomiting

Some people may also experience hypersensitivity reactions or anaphylaxis with SIGRIMA™, which are serious allergic reactions that can sometimes occur suddenly and are capable of affecting different areas of the body. These reactions have been reported to be fatal in some cases.⁹

The most commonly seen side effects of SIGRIMA™ + Trastuzumab + chemotherapy in those who are being treated for early breast cancer before surgery are^4,10:

• Constipation
• Diarrhea
• Decreased levels of RBCs
• Decreased levels of WBCs with/without fever
• Hair loss
• Headache
• Low platelet count
• Muscle pain
• Nausea and vomiting
• Nerve damage leading to symptoms like tingling feeling, numbness, or pain in limbs
• Rashes
• Weakness

NOTE: Side effects experienced changes during the chemotherapy regimen.

Commonly seen side effects of SIGRIMA™ when given in combination with Trastuzumab and chemotherapy as part of an early breast cancer regimen post surgery are^4,11:

• Diarrhea
• Hair loss
• Nausea and vomiting
• Nerve damage leading to symptoms like tingling feeling, numbness, pain in limbs
• Tiredness

Commonly seen side effects of SIGRIMA™ when given in combination with Trastuzumab and docetaxel for treatment of metastatic breast cancer (that has spread to different parts of the body) are^4,8,12:

• Decreased levels of WBCs with/without fever
• Diarrhea
• Hair loss
• Nausea
• Nerve damage leading to symptoms like tingling feeling, numbness, pain in limbs
• Tiredness
• Rash

It is advised that you report any side effects to Zydus pharmacovigilance cell (Contact center: 1800 419 1141 / Email: drugsafety@zyduslife.com). You should speak to your healthcare professional to learn more about the benefits and risks associated with the use of SIGRIMA™. It is also advised that you check out the entire prescribing information of the medicine for additional safety information and other possible side effects.

SIGRIMA™ (Pertuzumab) is a medicine prescribed by healthcare professionals in combination with Trastuzumab and chemotherapy¹³ in the following cases:

• For use before surgery as a neoadjuvant treatment¹⁴ in those with HER2+, locally advanced, inflammatory, or early-stage breast cancer (tumor size >2 cm in diameter or node-positive). For early breast cancer, SIGRIMA™ should be part of a complete therapy plan.⁴
• For use after surgery as an adjuvant treatment in those with HER2+ early breast cancer with a significant chance of returning back.^4,15

SIGRIMA™ (Pertuzumab) is a medicine prescribed by healthcare professionals and has been approved for treatment of people who have HER2+ metastatic breast cancer (that has spread to other parts of the body)¹⁰ and also who have not received anti-HER2 therapy or chemotherapy for metastatic breast cancer, in combination with Trastuzumab and docetaxel.⁴