Consumer medicine information

1. Why am I taking Darunavir Juno?

Darunavir Juno contains the active ingredient darunavir. Darunavir Juno is used in the treatment of HIV to reduce the risks of infection. Darunavir is given in combination with either cobicistat or ritonavir for the suppression of HIV.
For more information, see Section 1. Why am I taking Darunavir Juno? in the full CMI.

2. What should I know before I take Darunavir Juno?

Do not use if you have ever had an allergic reaction to darunavir or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I take Darunavir Juno? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Darunavir Juno and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I take Darunavir Juno?

Take Darunavir Juno exactly as directed by your doctor. Your doctor will decide which dose is right for you.
Adults: You must take Darunavir Juno every day and always in combination with 100 milligrams of ritonavir or 150 milligrams of cobicistat, and with food. You must eat a meal or a snack within 30 minutes prior to taking your Darunavir Juno and ritonavir or cobicistat.
Eligible children: The doctor will advise the correct dose based on the weight of the child.
More instructions can be found in Section 4. How do I take Darunavir Juno? in the full CMI.

5. What should I know while using Darunavir Juno?

6. Are there any side effects?

Like all medicines, Darunavir Juno can cause side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
Most common side effects include nausea, vomiting, headache, abdominal pain, diarrhoea, rash, weakness or lack of energy, feeling tired.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Darunavir.

2 Qualitative and Quantitative Composition

Each film-coated tablet contains 400 mg, 600 mg or 800 mg of darunavir.
For a full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Darunavir Juno 400 mg film-coated tablets are beige-coloured, oval shaped, biconvex, film coated tablets, debossed with "D" on one side and "400" on the other side.
Darunavir Juno 600 mg film-coated tablets are beige-coloured, oval shaped, biconvex, film coated tablets, debossed with "D" on one side and "600" on the other side.
Darunavir Juno 800 mg film-coated tablets are brown coloured, oval shaped, biconvex, film-coated tablets, debossed with "D" on one side and "800" on the other side.

4 Clinical Particulars

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).
Human experience of acute overdose with darunavir/rtv is limited. Single doses up to 3200 mg of the oral solution of darunavir alone and up to 1600 mg of the tablet formulation of darunavir in combination with ritonavir have been administered to healthy volunteers without untoward symptomatic effects.
There is no specific antidote for overdose with Darunavir Juno. Treatment of overdose with Darunavir Juno consists of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient. Since darunavir is highly protein bound, dialysis is unlikely to be beneficial in significant removal of the active substance.

5 Pharmacological Properties

Pharmacotherapeutic group: Antivirals for systemic use, protease inhibitors.
ATC code: J05AE10.

5.3 Preclinical Safety Data

Genotoxicity. Darunavir was not mutagenic or genotoxic in a battery of in vitro and in vivo assays including bacterial reverse mutation (Ames), chromosomal aberration in human lymphocytes and in vivo micronucleus test in mice.
Carcinogenicity. Darunavir was evaluated for carcinogenic potential by oral gavage administration to mice and rats up to 104 weeks. Daily doses of 150, 450 and 1000 mg/kg were administered to mice and doses of 50, 150 and 500 mg/kg were administered to rats. Systemic exposures at the highest dose (based on plasma AUC) were approximately 0.5-fold (mice) and 0.75-fold (rats) relative to humans at the recommended therapeutic dose of darunavir/ritonavir (600/100 mg b.i.d).
The incidences of hepatocellular adenomas were statistically significantly increased at all doses in male mice; at the mid and high dose in female mice and male rats; and at the high dose in female rats. The incidence of hepatocellular carcinomas was significantly increased at the high dose in male mice; and male and female rats. The relevance of these findings for humans is limited. An increase in the incidence of thyroid follicular cell adenomas was noted in male rats.
This is considered rodent specific and of no relevance to humans.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSDARUNA.gif CAS number. 206361-99-1.
Molecular formula: C₂₇H₃₇N₃O₇S.
Molecular weight: 547.66 daltons.
The chemical name for darunavir is [(1S,2R)-3-[[(4-aminophenyl)sulfonyl](2-methylpropyl)amino]-2-hydroxy-1-(phenylmethyl)propyl]-carbamic acid (3R,3aS,6aR)-hexahydrofuro[2,3-b]furan-3-yl ester.
Darunavir (amorphous) is a white to off-white powder that is insoluble in water, sparingly soluble in methanol, and soluble in dichloromethane.

7 Medicine Schedule (Poisons Standard)

Prescription Only Medicine (S4).

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/DARJUNST.gif