500 mg film-coated tablets
saquinavir
1. What Invirase is and what it is used for
Invirase contains the active substance saquinavir which is an antiviral agent. It belongs to a group of medicines called protease inhibitors which are used to treat HIV- 1 (human immunodeficiency virus ) infections.
Invirase is used to treat HIV- infected adults. Invirase is prescribed in combination with ritonavir (Norvir) and other antiretroviral medicines.
2. What you need to know before you take Invirase
Do not take Invirase if you have:
- an allergy to saquinavir, ritonavir or any of the other ingredients (see “Invirase contains lactose” later in this section and “Content declaration” in section 6)
- any heart problem that can be seen on an electrocardiogram ( ECG , electrical recording of the heart) – you may have been born with this.
- very slow heart rate ( bradycardia )
- a weak heart ( heart failure ).
- previously had irregular heartbeats ( arrhythmias )
- imbalance in blood salinity, especially if you have too low a concentration of potassium in your blood ( hypokalaemia ) and are not currently being treated for this
- severe liver disease such as jaundice, hepatitis or liver failure – with increased fluid in the abdominal cavity, becoming confused or bleeding from the esophagus
- recently taken the HIV drug rilpivirine
Do not take Invirase if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist.
Do not take Invirase if you are taking any of the following medicines:
Any medication that may change your heart rhythm, such as:
- certain medicines for HIV – such as atazanavir, lopinavir, rilpivirine
- certain cardiac drugs- amiodarone , bepridil, disopyramide , dofetilide, flecainide , hydroquinidine, ibutilide, lidocaine , propafenone , quinidine , sotalol
- certain medicines for depression- amitriptyline, imipramine, trazodone, maprotiline
- drugs for other severe mental problems such as clozapine, haloperidol , mesoridazine, phenothiazines, sertindole, sultoprid, thioridazine, ziprasidone)
- certain medicines for infectious diseases such as clarithromycin, dapsone, erythromycin, halofantrine, pentamidine, sparfloxacin
- certain strong painkillers (classified as drugs) such as alfentanyl, fentanyl , methadone
- erectile dysfunction drugs- sildenafil, vardenafil, tadalafi
- some medicines that can be used for several different things: cisapride, difemanil, mizolastine, quinidine , vincamine
- certain drugs used to prevent rejection of new organs after a transplant such as tacrolimus
- certain drugs used to treat the symptoms of benign prostatic hyperplasia, such as alfuzosin.
- certain drugs commonly used for allergic symptoms such as terfenadine and astemizole
- certain medicines for severe mental problems such as pimozide
- certain drugs (so-called tyrosine kinase inhibitors) that are used to treat various types of cancer such as. dasatinib and sunitinib
Any of the following other medicines:
- ergotamine derivatives – against migraine attacks
- triazolam and midazolam (taken by mouth) – used to help you sleep or for anxiety
- rifampicin- to prevent or treat tuberculosis
- simvastatin and lovastatin- to lower blood cholesterol
- quetiapine – used to treat schizophrenia, bipolar disorder and major depression
- lurasidone – used to treat schizophrenia
Do not take Invirase with any other medicine without first talking to your doctor. The medicines listed above can cause serious side effects if you take them with Invirase.
Do not take Invirase if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Invirase.
Warnings and cautions
Invirase/ritonavir is not a cure for HIV – infection and you may continue to develop infections you or other illnesses associated with HIV -sjukdom. You should therefore continue to contact your doctor while taking Invirase/ritonavir.
You can still transmit HIV infection while taking this medicine, even though the risk of effective antiviral therapy is reduced. Discuss with your doctor the necessary steps to avoid infecting others.
At present, only limited information is available on treatment with Invirase/ritonavir in children and adults over 60 years of age.
Abnormal heart rhythm ( arrhythmia ):
Invirase can change the way your heart beats – this can be serious. This can especially happen if you are a woman or older.
- If you are taking any medicine that lowers your blood potassium levels, talk to your doctor before taking Invirase.
- If you experience palpitations or irregular heartbeat during treatment, you should tell your doctor immediately. Your doctor may then want to do an ECG to check your heart rate.
Other conditions
There are some conditions that you may have or have had, that require extra care before and when using Invirase/ritonavir. You should therefore inform your doctor if you suffer from diarrhea, or if you are allergic (see section 4), or if you do not tolerate certain sugars (see section “Invirase contains lactose”) before you start using this medicine.
Kidney disease: Consult your doctor if you have or have had any kidney disease.
Liver disease: Consult your doctor if you have or have had any liver disease. Patients with chronic hepatitis B or C who are being treated with antiretroviral medicines are at increased risk of developing serious liver side effects, which can be life-threatening. Blood tests may be needed to check liver function.
Infections: In some patients with advanced HIV infection ( AIDS ) and who have previously had opportunistic infections, signs and symptoms of inflammation from previous infections may occur shortly after starting treatment for HIV. These symptoms are probably due to an improvement in the body’s immune response, which enables the body to fight infections that may have been present without any obvious symptoms. Tell your doctor immediately if you notice any symptoms of infection (see section 4).
In addition to opportunistic infections, autoimmune disorders (conditions in which the immune system attacks healthy body tissue) can also occur after you start taking medicines to treat your HIV infection. Autoimmune disorders can occur several months after starting treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, the weakness that starts in the hands or feet and moves to the torso, palpitations, tremors, or hyperactivity, informs your doctor immediately for the necessary treatment.
Bone problems: Some patients receiving combination antiretroviral therapy may develop a bone disease called osteonecrosis (bone tissue dies due to lost blood supply to the bone). Some of the many risk factors for developing the disease are long-term antiretroviral combination therapy, use of corticosteroids, alcohol consumption, a severe weakening of the immune system, and a higher body mass index. Signs of osteonecrosis are stiffness in the joints and pain (especially in the hip, knee, and shoulders) and difficulty moving. Tell your doctor if you experience any of these symptoms.
Other medicines and Invirase
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Invirase/ritonavir can be taken with a variety of drugs commonly used for the treatment of HIV – infection.
There are certain medicines that must not be taken with Invirase/ritonavir (see section “Do not take Invirase if you are taking any of the following medicines” above). There are also some medicines for which a dose needs to be reduced for that medicine or for Invirase or ritonavir (see section “Drugs that may interact with saquinavir or ritonavir include:” below). Ask your doctor or pharmacist for more information when taking Invirase/ritonavir with other medicines.
Drugs that may interact with saquinavir or ritonavir include:
- other HIV medicines such as nelfinavir, indinavir, nevirapine, delavirdine, efavirenz, maraviroc, cobicistat
- certain drugs that affect the immune system such as ciclosporin, sirolimus (rapamycin), tacrolimus
- various steroids – such as dexamethasone, ethinyl estradiol, fluticasone
- certain heart medications – such as calcium channel blockers , quinidine , digoxin
- drugs used to lower blood cholesterol – such as statins
- antifungals – ketoconazole , itraconazole, fluconazole , miconazole
- epilepsy drugs – such as phenobarbital, phenytoin , carbamazepine
- sedatives – such as midazolam given as an injection
- certain antibiotics – such as quinpristine / dalfopristine, rifabutin, fusidic acid
- drugs for the treatment of depression – such as nefazodone, tricyclic antidepressants
- blood thinners – warfarin
- natural remedies containing St. John’s wort or garlic capsules
- certain medicines that treat stomach acid diseases like omeprazole or other proton pump inhibitors
- drugs for the treatment of asthma or other lung diseases such as Chronic Obstructive Pulmonary Disease (COPD), such as salmeterol
- medicines for gout , such as colchicine
- medicament for the treatment of high blood pressure in the pulmonary artery s disease (a disease called pulmonary arterial hypertension ), as bosentan .
Therefore, you should not take Invirase/ritonavir with other medicines without consulting your doctor.
If you are taking birth control pills to prevent pregnancy, you should use an additional or different type of contraceptive as ritonavir may reduce the effectiveness of birth control pills.
Invirase with food and drink
Invirase should be taken with ritonavir and with or after a meal.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or if you may be pregnant. This medicine should not be used during pregnancy before consulting your doctor.
You should not breastfeed your baby if you are taking Invirase/ritonavir.
Driving and using machines
No studies have been performed. However, dizziness, fatigue, and visual impairment have been reported during treatment with Invirase. Do not drive or use machines if you experience these symptoms.
Invirase contains lactose
Each film-coated tablet contains 38.5 mg of lactose (monohydrate). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Invirase
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. Invirase is available as a 500 mg film-coated tablet. Your doctor will prescribe Invirase in combination with ritonavir (Norvir) and other HIV medicines
How to take
- Take Invirase while you are taking your ritonavir capsule (Norvir).
- Take your Invirase capsule with or after food.
- Swallow them whole with water.
How much to take
Normal dos
- Take two 500 mg film-coated tablets of Invirase twice a day.
- Take one 100 mg capsule of ritonavir (Norvir) twice a day.
If this is your first drug for HIV or if it is your first time taking ritonavir (Norvir), you will need to take a lower dose of Invirase during the first week.
Week 1:
- Take a 500 mg film-coated tablet of Invirase twice a day.
- Take one 100 mg capsule of ritonavir (Norvir) twice a day.
Week 2 and onwards:
- Continue with the standard dose
If you take more Invirase than you should
If you have taken more than the prescribed dose of Invirase/ritonavir, you must contact your doctor or pharmacist.
If you forget to take Invirase
Do not take a double dose to make up for a forgotten dose. If you forget to take a dose, take that dose with some food as soon as you remember. Then continue as before. Never change the prescribed dose yourself.
If you stop taking Invirase
Keep taking this medicine until your doctor tells you to do something else.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
During HIV treatment, weight gain and increased levels of lipids and glucose may occur. This is partly related to restored health and lifestyle, but when it comes to blood lipids, there may sometimes be a link with HIV drugs. The doctor will perform tests to find such changes.
In the treatment of HIV – infection, it is not always possible to differentiate between unwanted effects caused by Invirase or by any of the other medicines you take at the same time or by the complications of the infection a. For these reasons, it is very important that you inform your doctor in the event of a change in your state of health.
The most common side effect is (in more than 10 of 100) of saquinavir taken with ritonavir from the gastrointestinal tract, such as nausea, diarrhea, fatigue, vomiting, flatulence, and abdominal pain. Changes in laboratory values (eg blood or urine samples) are also very common.
Other side effects ( in more than 1 in 100 but less than 1 in 10 users ) that may occur are rash, itching, eczema, and dry skin, hair loss and dry mouth, headache, peripheral neuropathy (nerve disorders in the feet and hands that can take expression in the form of loss of sensation, crawling or burning pain), weakness, dizziness, problems with sex drive, taste changes, cold sores, dry lips, fluid loss, stomach upset, indigestion, weight loss, constipation, increased appetite, muscle spasms and shortness of breath.
Another less common side effect is (more than 1 in 1000 but less than 1 in 100) comprises; decreased appetite, visual disturbances, inflammation of the liver, seizures, allergic reactions, blisters, drowsiness, abnormal kidney function, inflammation of the pancreas, yellow skin or whites of the eyes due to liver problems and Steven’s Johnson syndrome (a serious disease with blisters on the skin, eyes, mouth and the genitals).
In patients with haemophilia type A and B, there have been reports of an increased tendency to bleed when taking this or another protease inhibitor. If this happens to you, talk to your doctor straight away.
There are reports of muscle pain, tenderness, or weakness in the muscles, especially in combination with antiretroviral therapy with protease inhibitors and nucleoside analogues . In rare cases, these muscle problems have been severe ( rhabdomyolysis ).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store Invirase
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the can and carton after EXP. date. The expiration date is the last day of the specified month.
No special storage instructions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Marketing Authorization Holder and Manufacturer
Content declaration
- The active substance is saquinavir. One film-coated tablet, Invirase, contains 500 mg saquinavir as saquinavir mesilate.
- The other ingredients (excipients) are microcrystalline cellulose, crushed caramel sodium, povidone, lactose (monohydrate) 38.5 mg, magnesium stearate, hypromellose, titanium dioxide (E171), talc, glycerol triacetate, yellow and red iron oxide (E172).
What the medicine looks like and contents of the pack
Invirase 500 mg film-coated tablets are light orange to greyish or brown-orange film-coated tablets with an oval shape marked “SQV 500” on one side and “ROCHE” on the other side. A plastic jar (HDPE) contains 120 tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Roche Registration GmbH
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany
Manufacturer
Roche Pharma AG,
Emil Barell-Strasse 1,
79639 Grenzach-Wyhlen,
Germany
For any information about this medicine, please contact the local representative of the Marketing Authorization Holder.
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This leaflet was last amended in August 2021
Other sources of information
Further information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu