100 mg / 300 mg / 245 mg film-coated tablets 
doravirin / lamivudine / tenofovir disoproxil

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • 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. See section 4.

This leaflet contains information about: 
1. What Delstrigo is and what it is used for 
2. What you need to know before you take Delstrigo 
3. How to take Delstrigo 
4. Possible side effects 
5. How to store Delstrigo 
6. Contents of the packaging and other information 

1. What Delstrigo is and what it is used for

What Delstrigo is

Substring is used to treat HIV (“human immunodeficiency virus”) infection. It belongs to a group of medicines called “antiretroviral medicines”.

Substring contains the active substances:

  • Moravian – a non-nucleoside reverse transcriptase inhibitor (NNRTI)
  • lamivudine – a nucleoside reverse transcriptase inhibitor (NRTI) analogue
  • tenofovir disoproxil – a nucleoside reverse transcriptase inhibitor (NRTI) analogue.

What Delstrigo is used for

Substrigo is used to treat HIV infection in people aged 18 and older. HIV is the virus that causes AIDS (“acquired immune deficiency syndrome”). You should not take Delstrigo if your doctor has told you that the virus that causes your infection is resistant (resistant) to any of the active substances in Delstrigo.

How Delstrigo works

Delstrigo works by preventing HIV from making more viruses in your body. It helps by:

  • reduce the amount of HIV in the blood (the so-called “amount of virus”)
  • increase the number of white blood cells, so-called “CD4  T”. It can make your immune system stronger and can reduce the risk of premature death or getting infected because your immune system is weak.

2. What you need to know before you take Delstrigo

Do not take Delstrigo

  • if you are allergic to Moravian, lamivudine or tenofovir disoproxil, or any of the other ingredients of this medicine (listed in section 6).
  • if you are taking any of the following medicines:
    • carbamazepine, oxcarbazepine, phenobarbital, phenytoin (anticonvulsant)
    • rifampicin, rifapentine (a medicine used to treat tuberculosis )
    • St. John’s wort ( Hypericum perforatum, a herbal remedy for depression and anxiety) or products containing St. John’s wort
    • mitotane (anti-cancer drug)
    • enzalutamide (a drug for prostate cancer)
    • lumacaftor (a drug for cystic fibrosis )

Do not take Delstrigo if any of the above apply to you. If you are not sure, talk to your doctor, pharmacist, or nurse before taking Delstrigo. See also section “Other medicines and Delstrigo”.

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before taking Delstrigo.

Transmission of HIV to others

HIV is spread through contact with blood or through sexual contact with a person who has HIV. You can still infect others with HIV when you take Delstrigo, although effective treatment reduces the risk. Talk to your doctor about what you can do to avoid infecting others.

Exacerbated hepatitis B infection

If you have both HIV and hepatitis B virus infections, your hepatitis B may get worse if you stop taking Delstrigo. You may need to submit blood samples for several months after stopping treatment. Discuss your hepatitis B treatment with your doctor.

New or worsening kidney problems, including kidney failure

This may happen to some people taking Delstrigo. Your doctor will take blood samples to check your kidney function before and during treatment with Delstrigo.

Skeletal problem

This may happen to some people taking Delstrigo. Skeletal problems include skeletal pain, softer or thinner skeletons (which can lead to bone fractures). Joint or muscle pain or muscle weakness may also occur. Your doctor may need to take more samples to check your skeleton.

Immune reactivation syndrome

This is something that can happen when you start taking HIV medicine, including Delstrigo. Your immune system can become stronger and start fighting infections that have been hidden in your body for a long time. Tell your doctor immediately if you get any new symptoms once you have started your HIV treatment.

Autoimmune disorders (a condition in which the immune system attacks healthy body tissue) may 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, a weakness that starts in the hands or feet and moves to the torso, palpitations, tremors, or hyperactivity, inform your doctor immediately for the necessary treatment.

Children and young people

Do not give this medicine to anyone under 18 years of age. The use of Delstrigo in people under 18 years of age has not yet been studied.

Other medicines and Delstrigo

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines. This is because other medicines may affect the way Delstrigo works and Delstrigo may affect the way some other medicines work.

There are certain medicines that you must not take Delstrigo with. See the list under the section “Do not take Delstrigo”.

Talk to your doctor before taking the following medicines at the same time as Delstrigo as your doctor may need to change the dose of one of your medicines:

  • bosentan (a medicine used to treat lung diseases)
  • dabrafenib (medicine for skin cancer)
  • lesinurad (medicine for gout )
  • modafinil (a medicine used to treat excessive sleep)
  • nafcillin (medicine for certain bacterial infections)
  • rifabutin (medicines for certain bacterial infections, such as tuberculosis )
  • telotristatetyl (antiarrhythmic drug in people with carcinoid syndrome)
  • thioridazine (a medicine used to treat mental disorders such as schizophrenia).

If your doctor decides that you should take these medicines with Delstrigo, your doctor will prescribe a 100 mg tablet of Moravian to be taken daily approximately 12 hours after your dose of Delstrigo.

Your doctor may check your blood levels or monitor for side effects if you are taking the following medicines with Delstrigo:

  • ledipasvir/sofosbuvir (medicines for hepatitis C infection )
  • sirolimus (a medicine used to control your body’s immune response after a transplant)
  • sofosbuvir / velpatasvir (medicines for hepatitis C infection )
  • tacrolimus (a medicine used to control your body’s immune response after a transplant)
  • medicines (often liquid) containing sorbitol or other sugar alcohols (such as xylitol, mannitol, lactitol, or maltitol), if taken regularly

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice on the risks and benefits of taking Delstrigo. It is preferable to avoid the use of Delstrigo during pregnancy. This is because it has not been studied during pregnancy and it is not known if Delstrigo will harm your baby when you are pregnant.

Women with HIV should not breast-feed because HIV can be transmitted to the baby through breast milk. Talk to your doctor about the best way to feed your child.

Driving and using machines

Caution should be exercised if you drive, cycle or use machines if you feel tired, dizzy, or sleepy after taking this medicine.

Substrigo contains lactose

If you have been told by your doctor that you have lactose intolerance, talk to your doctor before taking this medicine.

3. How to take Delstrigo

Always take this medicine exactly as your doctor, pharmacist or nurse has told you. If you are not sure, talk to your doctor, pharmacist, or nurse. Delstrigo is a complete combination treatment administered as one tablet for the treatment of HIV – infection.

How much to take

The recommended dose is one tablet once a day. If you are taking certain medicines, your doctor may need to change the dose of a Moravian you are taking. See section “Other medicines and Delstrigo” for a list of medicines.

How to take this medicine

  • Swallow the tablet whole (it must not be crushed or chewed).
  • This medicine can be taken with food or between meals.

If you take more Delstrigo than you should

Do not take more than the recommended dose. If you happen to take more, contact your doctor.

If you forget to take Delstrigo

  • You mustn’t miss or skip a dose of Delstrigo.
  • If you forget to take a dose, take it as soon as you remember. But if it is time for your next dose within 12 hours, you should instead skip the missed dose and take the next dose at the usual time. Then continue with the treatment as before.
  • Do not take two doses of Delstrigo at the same time to compensate for a missed dose.
  • Contact your doctor or pharmacist if you are not sure what to do.

If you stop taking Delstrigo

Make sure you do not run out of Delstrigo. Renew your prescription or talk to your doctor before all Delstrigo is over.

If you stop taking Delstrigo doctor must check your health and often take blood samples at intervals of several months to check your HIV – infection. If you have HIV – infection and hepatitis B infection, it is especially important not to stop taking Delstrigo without first talking to your doctor. In some patients, blood tests or symptoms have shown that hepatitis one has worsened when they stop taking or tenofovir disoproxil (two of the three active substances in Delstrigo). If you stop taking Delstrigo, your doctor may recommend that you resume treatment for hepatitis B. You may need blood tests to check how your liver is working for 4 months after stopping treatment. For some patients with advanced liver disease or liver cirrhosis (cirrhosis of the liver ), it is not recommended to stop treatment as it may make hepatitis worse, which can be life-threatening.

If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Do not stop taking this medicine without talking to your doctor first.

Common: may affect up to 1 in 10 people:

  • abnormal dreams, difficulty sleeping ( insomnia )
  • headache, dizziness, drowsiness
  • cough, nasal symptoms
  • nausea, diarrhea, abdominal pain, vomiting, gas ( flatulence )
  • hair loss, rash
  • muscle symptoms (pain, stiffness)
  • fatigue, fever

Blood tests may also show:

  • elevated levels of liver enzymes ( ALT )

Uncommon: may affect up to 1 in 100 people:

  • nightmares, depression, anxiety, irritability, confusion, suicidal thoughts
  • difficulty concentrating, impaired memory, tingling in hands and feet, stiff muscles, poor sleep quality
  • high blood pressure
  • constipation, abdominal discomfort, swollen or bloated stomach, indigestion, loose stools, stomach cramps, frequent bowel movements, inflammation of the pancreas ( pancreatitis ) (causes abdominal pain, vomiting)
  • itching
  • joint pain, degradation of muscle tissue, muscle weakness
  • the feeling of weakness, a general feeling of illness

Blood tests may also show:

  • decreased number of white blood cells in the blood ( neutropenia )
  • decreased number of red blood cells in the blood ( anemia )
  • decreased levels of platelets in the blood (you can bleed more easily)
  • decreased levels of phosphate
  • decreased levels of potassium in the blood
  • elevated levels of creatinine in the blood
  • elevated levels of liver enzymes ( ASAT )
  • elevated levels of lipase
  • elevated levels of amylase
  • decreased levels of hemoglobin

Muscle pain, muscle weakness, and decreased amount of potassium or phosphate in the blood can be due to damage to the small channels in the kidneys.

Rare: may affect up to 1 in 1,000 people

  • aggression, hallucinations, difficulty adapting to changes, mood swings, sleepwalking
  • difficulty breathing, enlarged tonsils
  • the feeling of incomplete bowel movements
  • enlarged liver or fatty liver, yellowing of the skin or eyes, abdominal pain caused by inflammation of the liver
  • inflammation of the skin due to allergies, redness of the cheeks, nose, chin, or forehead, lumps or pimples on the face, swelling of the face, lips, tongue, or throat
  • muscle weakness, weakening of the skeleton (with skeletal pain and sometimes resulting in bone fractures)
  • kidney damage, kidney stones, kidney failure, damage to the small ducts in the kidneys, kidney damage, copious amounts of urine, and thirst
  • chest pain, chills, pain, thirst

Blood tests may also show:

  • decreased levels of magnesium
  • lactic acidosis (excess lactic acid in the blood)
  • elevated levels of creatine phosphokinase

Very rare: may affect up to 1 in 10,000 people

Blood tests may also show:

  • the inability of bone marrow to produce new red blood cells (lack of red blood cells alone )

5. How to store Delstrigo

  • 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 after EXP.
  • The jar contains a desiccant that protects the tablets from moisture. There may be more than one in a jar. Leave the desiccant in the jar and do not throw it away until you have taken all the tablets.
  • Close the jar tightly. Moisture sensitive.
  • No special temperature 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

Content declaration

  • The active substances are 100 mg doravirin, 300 mg lamivudine and 245 mg tenofovir disoproxil (as fumarate)
  • The other ingredients are croscarmellose sodium E468, hypromellose acetate succinate, magnesium stearate E470b, microcrystalline cellulose E460, colloidal anhydrous silica E551, and sodium stearyl fumarate. The tablets have a film coating consisting of the following ingredients: carnauba wax E903, hypromellose E464, yellow iron oxide E172, lactose monohydrate, titanium dioxide E171, and triacetin E1518.

What the medicine looks like and the contents of the pack

Delstrigo is a yellow, oval, film-coated tablet, marked with the company logo and “776” on one side and smooth on the other.

The following pack sizes are available:

  • 1 jar of 30 film-coated tablets
  • 90 film-coated tablets (3 cans of 30 film-coated tablets)

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Merck Sharp & Dohme BV

Waarderweg 39

2031 BN Haarlem

Netherlands

Contact the representative of the marketing authorization holder to find out more about this medicine:

Belgium / Belgique / BelgienMSD Belgium BVBA / SPRLTel: +32 (0) 27766211dpoc_belux@merck.com LithuaniaUAB Merck Sharp & DohmeTel. + 370 5 278 02 47msd_lietuva@merck.com
BulgariaMark Harp and Doom Bulgaria BulgariaTel: +359 2 819 3737info-msdbg@merck.com Luxembourg / LuxemburgMSD Belgium BVBA / SPRLTel: +32 (0) 27766211dpoc_belux@merck.com
Czech RepublicMerck Sharp & Dohme sroTel: +420 233 010 111dpoc_czechslovak@merck.com HungaryMSD Pharma Hungary Kft.Tel .: +36 1 888 5300hungary_msd@merck.com
DenmarkMSD Danmark ApSTel: + 45 4482 4000dkmail@merck.com MaltaMerck Sharp & Dohme Cyprus LimitedTel: 8007 4433 (+356 99917558)malta_info@merck.com
GermanyMSD SHARP & DOHME GMBHTel: 0800 673 673 673 (+49 (0) 89 4561 2612)e-mail@msd.de The NetherlandsMerck Sharp & Dohme BVTel: 0800 9999000(+31 23 5153153)medicalinfo.nl@merck.com
EestiMerck Sharp & Dohme OÜTel .: +372 6144 200msdeesti@merck.com NorwayMSD (Norway) ASTel: +47 32 20 73 00msdnorge@msd.no
GreeceMSD Α.Φ.Β.Ε.Ε.:Ηλ: +30 210 98 97 300dpoc_greece@merck.com AustriaMerck Sharp & Dohme Ges.mbHTel: +43 (0) 1 26 044msd-medizin@merck.com
SpainMerck Sharp & Dohme de España, SATel: +34 91 321 06 00msd_info@merck.com PolandMSD Polska Sp. z ooTel: +48 22 549 51 00msdpolska@merck.com
FranceMSD FranceTel: + 33 (0) 1 80 46 40 40 PortugalMerck Sharp & Dohme, LdaTel: +351 21 4465700inform_pt@merck.com
Croatia:Merck Sharp & Dohme dooTel: + 385 1 6611 333croatia_info@merck.com RomaniaMerck Sharp & Dohme Romania SRLTel: +40 21 529 29 00msdromania@merck.com
IrelandMerck Sharp & Dohme Ireland ( Human Health) LimitedTel: +353 (0) 1 2998700medinfo_ireland@merck.com SloveniaMerck Sharp & Dohme, an innovative freelance dooTel: +386 1 5204 201msd.slovenia@merck.com
IcelandVistor hf.Phone: + 354 535 7000 Slovak RepublicMerck Sharp & Dohme, sroTel: +421 2 58282010dpoc_czechslovak@merck.com
ItalyMSD Italia SrlTel: +39 06 361911medicalinformation.it@merck.com Finland / FinlandMSD Finland OyPuh / Tel: +358 (0) 9 804 650info@msd.fi
LatviaSIA Merck Sharp & Dohme LatvijaTel: + 371 67364224msd_lv@merck.com United KingdomMerck Sharp & Dohme LimitedTel: +44 (0) 1992 467272medicalinformationuk@merck.com

Muhammad Nadeem

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