procedure of infusion
SIGRIMA™ is given every 3 weeks as an IV infusion1
SIGRIMA™ is administered via IV infusion, delivering the medication directly into the bloodstream through a vein.1
As IV infusions
Once every
3 weeks
Till cancer is under control
Your doctor will begin the treatment with SIGRIMA™, Trastuzumab, and docetaxel sequentially.1 Over time, adjustments may be made to your medication regimen as needed based on your tolerance.1,2
You may continue treatment with SIGRIMA™ and Trastuzumab even if docetaxel is required to be stopped.2
But if Trastuzumab is discontinued, then SIGRIMA should also be discontinued.1
What is the duration of each infusion1?
Infusion times may vary from person to person depending on tolerability.2
After each medication is given, your doctor or nurse will wait 30 to 60 minutes to check for any reactions. If a reaction occurs, they may adjust, delay, or stop treatment.1
SIGRIMA
infusions
Trastuzumab
infusion
Docetaxel
infusion
Beginning of the first treatment
During your first treatment
During the initial visit, medications are administered at a slower pace.
SIGRIMA™ will be given over a 60-minute period, Trastuzumab over 90 minutes,1 and docetaxel over 60 minutes.
How long will you stay on therapy?
Docetaxel is given for a minimum of 6 cycles. If your doctor stops docetaxel (for example, due to side effects), you can continue receiving Sigrima™ and Trastuzumab.2 You can stay on Sigrima™ and Trastuzumab until your disease is no longer controlled or your side effects require you to stop treatment.2 SIGRIMA™ therapy should also be postponed or discontinued if Trastuzumab therapy is delayed or stopped.1
Side Effects May Occur With SIGRIMATM
What are the most serious side effects of SIGRIMA™?
- Treatment with SIGRIMA™ during pregnancy can harm the fetus, leading to death of the fetus, or may cause major birth defects.1
- SIGRIMA™ can cause heart problems, such as reduced heart function, which has reduced heart function and is asymptomatic.1
What are other possible serious side effects of SIGRIMA™?
- SIGRIMA™ should be avoided in patients who are allergic to Pertuzumab or to any of the ingredients present in the SIGRIMA™ formulation.1
- Serious or fatal side effects may be related to infusion or allergic reactions (anaphylaxis/hypersensitivity).1
- The most common side effects of SIGRIMA™ in combination with Trastuzumab and docetaxel are low white blood cell count levels with or without fever, diarrhea, hair loss, excessive tiredness, nausea, rashes, and nerve damage causing weakness, numbness, and tingling in hands and feet.1
Your side effects may differ depending on your chemotherapy regimen.3
If you experience any side effects, discuss them with your doctor. You can try the tips below.
The suggestions provided below may not be effective for all patients. It is recommended to consult with your doctor prior to attempting any of these recommendations.
Diarrhea means you have loose or watery stools 3 or more times a day.4
Tips to manage diarrhea5
- Avoid fried, greasy, fatty, spicy, and pickled foods and fizzy drinks.
- Eat nutritious foods like fresh fruits, vegetables, and lentils.
- Have foods like rice, potatoes, and bananas that make your stools firmer.
- Have plenty of water and clear soups.
- Eat several small meals throughout the day instead of large meals.
Alopecia, or hair loss, can affect any part of the body.3,5
Tips to manage alopecia3,5
- Use a mild shampoo and avoid washing your hair on a day-to-day basis.
- Avoid using hair dryers, clips, and gels.
- Brushing, curling and blow-drying should be kept to a minimum when your hair is growing back.
- When outdoors, apply a sunscreen on your scalp or wear a hat or scarf.
Nausea is an unpleasant feeling in your stomach that may come and go in the form of waves. This usually occurs before vomiting, when you may throw up the contents of the stomach through the mouth.7
Tips to manage nausea and vomiting8,9
- Practice relaxation techniques like deep breathing or visualising a happy scenario to divert your mind from nausea.7
- Avoid fatty, sweet, and fried foods.9
- Cool down the food before eating if the smell of the hot food is making you feel nauseated.9
Fatigue is a sensation of weariness or depletion that can impact your capacity to engage in regular tasks.10,11
Tips to manage fatigue
- Engage in daily physical activity if approved by your doctor, as it can potentially maintain your strength11 and improve appetite and weight.
- Prioritize activities during periods when you feel most energetic.10,11
- Tackle essential tasks before others.10
During treatment, it’s possible to experience constipation and encounter challenges with bowel movements.12
Here are some suggestions you might consider.12
- Stay hydrated by drinking ample liquids.
- Incorporate high-fiber foods into your diet, such as whole-grain breads and cereals, fruits and vegetables, as well as nuts, seeds, and popcorn.
- Engage in physical activity whenever possible.
Important Safety Information
Are there any side effects of SIGRIMA™ I should look out for?
While the severe side effects of SIGRIMA™ are not experienced by everyone, side effects from SIGRIMA™ are common.1 So, it is important for you to know the symptoms and side effects one should look out for.
In case the side effects start becoming more serious, your doctor may stop the treatment. This is why you shouldimportantsafety report the side effects you are worried about to your doctor, and be sure to ask all your queries regarding the treatment.
What are the most serious side effects of SIGRIMA™?
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
Can pregnant women take SIGRIMA™?
Treatment with SIGRIMA™ in pregnant women may lead to birth defects or the death of the unborn child.5,6
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.
Are there any other serious side effects to look out for while taking SIGRIMA™?
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
What are the commonly seen side effects of SIGRIMA™?
The most commonly seen side effects of SIGRIMA™ + Trastuzumab + chemotherapy in those who are being treated for early breast cancer before surgery are4,10:
- 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 are4,11:
- 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) are4,8,12:
- 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.
What is SIGRIMA™ used for treating?
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